OTC - PANEL SUBMISSIONS - INDICES ONLY
01 Antacid
75N-0357
02 Antimicrobial
I
75N-0183
03 Internal
Analgesic
77N-0094
04 Cough-Cold
76N-0052
76N-052B Bronchodilators
76N-052C
Anticholinergics & Expectorants
76N-052G
General Comments & Combinations
76N-052H
Antihistamines
76N-052N
Nasel Decongestants
76N-052T
Antiussives
05 Sleep-Aids
75N-0244
06 Topical
Analgesic
77N-0334
Topical Otics
78N-0021
Skin Protectants
78N-0038
Sunscreen
78N-0301
External Analgesic
07 Antimicrobial
II
80N-0476
Topical Antifungal
81N-0114
Topical Acne
08 Dentifrices
and Dental Care Agents
78N-0196
Oral Mucosal Injury
80N-0042
Anticaries
80N-0228
Oral Discomfort
09 Laxatives
78N-0036
78N-036A
Antiemetic
78N-036D
Antidiarrheal
78N-036E
Emetic
78N-036L
Laxative
10
Ophthalmic
80N-0145
11 Contraceptives
and Other Vaginal Drug Products
80N-0280
Contraceptives
82N-0291
Vaginal
12 Memorrhoidal
(Anorectal)
80N-0050
13 Oral
Cavity
81N-0033
14 Antiperspirant
75N-0003
Zirconium
78N-0064
Antiperspirant
15 Vitamin
and Mineral
78N-0024
16 Misc
External
75N-0176
Request for Data and Information
75N-0183
Mercury-containing Drug Products for Topical Antimicrobial OTC Human
Use
75N-0183
Alcohol Drug Products for Topical Antimicrobial OTC Human Use
75N-0183
Diaper Rash
78N-0021
Astringent Drug Products
78N-0021
Diaper Rash
78N-0021
Externally Administered Fever Blister Drug Products
78N-0021
Insect Bite Neutralizer
78N-0021
Poison Ivy, Oak, and Sumac Prevention DRUG pRODUCTS
78N-0065
Skin Bleaching
78N-0301
Astringent Drug Products
78N-0301
Diaper Rash
78N-0301
Externally Administered Fever Blister Drug Products
78N-0301
Insect Bite Neutralizer
78N-0301
Male Genital Desensitizing
78N-0301
Poison Ivy, Oak, and Sumac Prevention Drug Products
80N-0146
Nailbiting and Thumbsucking Deterrent
80N-0227
Camphorated Oil
80N-0238
Wart Remover
80N-0348
Ingrown Toenail
80N-0357
Hair Grower and Sebum Hair Loss
80N-0476
Diaper Rash
81N-0122
Corn and Callus Remover
81N-0144
Topically Applied Hormone-containing Drug Products
82N-0054
Boil Ointment
82N-0214
Dandruff, Seborrheic Dermatitis and Psoriasis
17 Misc
Internal
75N-0176
Request for Data and Information
77N-0094
Quinine for Treatment of Nocturnal Leg Muscle Cramps
79N-0176
Stomach Acidifiers
79N-0177
Sweet Spirits of Nitre
79N-0368
Cholecystokinetic Drugs
79N-0378
Anthelmintic Drugs
79N-0379
Exocrine Pancreatic Insufficiency Drugs
80N-0395
Hypophospatemia and Hyperphosphatemia Drug Products
80N-0419
Aphrodisiac Drug Products
81N-0022
Weight Control
81N-0027
Smoking Deterrent
81N-0040
Insect Repellent
81N-0050
Acute Toxic Ingestion
81N-0060
Orally Administered Treatment for Fever Blisters
81N-0064
Deodorant Drug Products for Internal Use
81N-0106
Digestive Aid
82N-0165
Menstrual Drug Products
82N-0166
Overindulgence in Alcohol & Food
82N-0168
Benign Prostatic Hypertrophy
18 Stimulants
75N-0244
19 Tropical
Antibiotics (Antimicrobial II)
76N-0482
TITLE CFR
PART NO.
01 Antacid
& Antiflatulent 331
& 332
75N-0357
05 Sleep-Aids 310.519
75n-0244
Daytime Sleep-Aids
14 Antiperspirnat 310.510
75N-0003
Zirconium
15 Vitamin
and Mineral Withdrawn
78N-0024
16 Misc
External 310.526
80N-0227
Camphorated Oil
17 Misc
Internal 310.525
79N-0177
Sweet Spirits of Nitre 357
79N-0368
Cholecystokinetic Drugs
VOLUME # |
COMPANY |
PRODUCTS |
01 |
Plough Inc. |
Dl-Gel liquid
tablets |
02 |
Smith, Miller,
& Parch Inc. |
Alzinex
tablets magma |
03 |
American
Cyannaid Co. |
Aciban Antacid
tablets |
04/05 |
Ayerst
Laboratories Inc. |
Riopan susp.
Chew tablets |
06 |
|
Bisodol
tablets powder Bisodol plus
with Belladonne plus tablets |
07/08 |
A.H. Robins
Co. |
Silain tablets Silain-gel
tablets liquid |
09 |
A.H. Robins
Co. |
Robalate
liquid tablets |
10 |
Lewis Howe Co. |
Tums liquid |
11 |
Arch Labs |
Dicarbosil No.
2 Liquid |
12 |
Lewis Howe Co. |
Milk of
Magnesia |
13 & 52 |
Wyeth Lab. |
A-M-T susp. Aludrox susp.
Tablets Amphojel susp w/ mineral oil tablets, 300 mg. susp. 0.6 gm. tablets Basaljel Phosphaljel |
14 |
Riker |
Titralac
tablets liquid tablets for Military |
15 |
Sterling Drug |
Aluminum
Hydroxide |
16 |
Sterling Drug |
Magnesium
Trisililicate |
17 |
Sterling Drug |
Calcium
Carbonate |
18 |
Sterling Drug |
Antacids |
19 |
Phillips,
Chas. H. |
Phillips 203 |
20 |
Winthrop
Products Inc. |
Creamalin gel.
tablets Pepsamar
Tablets gel. |
21 |
|
Creamalin
liquid |
22 |
|
Creamalin ESP
liquid tablets |
23 |
|
Tricreamalata
liquid tablets |
VOLUME # |
COMPANY |
|
24 |
|
Wingel tablets
liquids |
25 |
Breon Lab Inc. |
Al-Caroid
tablets powder |
26 |
Phillips,
Ches. N. Co. |
Phillips’ Milk
of Magnesia Phillips’ Milk
of Magnesia tab. |
27 |
Sterling Drug
Inc. |
Sal Andrews |
28 |
Sterling Drug |
Fizrin |
29 |
Sterling Drug |
Haley’s M-O
Regular & flavored Mil-Par |
30/31 |
Lewis Howe Co. |
Tums Tums Cherry Tums Orange Tums Lemon Tums
Wintergreen |
31 |
Arch Labs. |
Dicarbosil |
32 |
Allen Pharmacy Boericke &
Ranyon Boericke &
Tafel Bullard Co. Case Labs.
Inc., G.M. Faraday Labs.
Inc. G.M. Case Labs Gibbs Medicine
Co. T.R. Henry Lab.
Inc. |
Flik Comb. tablet
#9 Comb. tablet
#33 Comb. tablet
#249 Alpha #46
tablet Anti-acid
tablets Carbo-Pancreatin
Pepsin tablets Comb. tablets
#117 Digestive
compound tablets Digestive
mixture Flik tablets Antacid
tablets Antiacid
tablets Push powder Formula 1447 |
VOLUME # |
COMPANY |
PRODUCTS |
32 |
Savoy Drug
& Chem’l Co. (for Vita Tone
Co.) Schosburg,
House of Scott
Labs. Inc. |
Anacid tablets Special
formula Special
formula Schomburg
powder Citrate of
Magnesia |
32 & 105 |
Mallinckrodt
Chem’l Works |
Krem tablets |
33 |
Vitamininerais
Inc. |
VM 21 |
34 |
Marion Lab. |
Gavisoon
foamtate |
35/37 |
Vick Chemical
Co. |
Vanamail
Antacid tablet liquid |
38 |
Warren-Teed |
Ratio tablets |
39 |
Humphreys
Pharmacal Inc. |
Papsomax
powder |
40 |
Garfield &
Co. |
Soidlitz
powders |
41 |
Beecham Inc. |
Eno |
42 |
C.S. Dent
& Co. |
Bell-ans |
43 |
Barnhoft Labs. Formulations
Inc. Phillips-Roxane |
Giycinate tablets Amaze Aids Aluminum
Hydroxide Antacid 34 Hykasil Cream Magnesia and
Alumina oral susp. Milk of
Magnesia |
43 & 45 |
Bowman
Pharmaceuticals Inc. |
Digestrogen
tabs. |
45 |
Bowman
Pharmaceuticals Inc. |
Antacid tabs.
#2 Tabs Bowcid Liquid Milk of
Magnesia Magnasil w/
Calcium Carbonate Milk og
Magnesia Sode Mint 5
gr. white Sodium
Bicarbonate 5 gr. White Sodium
Bicarbonate 5 gr. Pink |
50 |
Rorer Inc. |
Maalox |
51 |
Rorer Inc. |
Camalox susp.
tablet |
52 |
Wyeth Lab. |
A-N-T susp. |
52 & 13 |
Wyeth Lab. |
A-N-T susp. Aludrox susp. tablets Amphojel susp
w/mineral oil tablets Amphojel susp
tablets Basaljel Phosphaljel |
VOLUME # |
COMPANY |
PRODUCTS |
53/58 |
Merreil-National
Labs. |
Dalcid |
59 |
Merreil-National
Labs. |
Kolantyl Kolantyl tabs
wafers |
60 |
Miles Lab.
Inc. |
Alka Seltzer |
61 |
Upjohn Co. |
Alkets |
62 |
Medical
Chemicals Co. |
Medicil Madulox |
62 |
E.R. Squibb |
Milk of
Magnesia tablet liquid Mint-o-Mag |
63 |
FDA Library |
Antacid
literature search |
64/70 |
Miles Lab.
Inc. |
Alka-Seltzer |
71/73 |
Warner-Lambert |
Rolaids |
74/76 |
Warner-Lambert |
Rolaids liquid |
77/79 |
Warner-Lambert |
Broomo Seltzer |
80 |
Warner-Lambert |
Macotin |
81 |
Warner-Lambert |
Gelusil Lac. |
82 |
Warner-Lambert |
Gelusil N
liquid |
83 |
Warner-Lambert |
Gelusil N
tablets |
84 |
Warner-Lambert |
Gelusil
tablets |
85 |
Warner-Chilcott |
Gelusil Flavor
Pak |
86 |
Warner-Lambert |
Gelusil liquid |
87 |
Church &
Delight |
Sodium
Bicarbonate |
88 |
lCl American
Inc. |
Mylanta
tablets liquid Mylanta II
tablets liquid |
89 |
Plough Inc. |
|
90 |
Kremer Urban |
Kudrox tablets
liquid |
91 |
Sterling Drug |
Phillips Milk
of Magnesia |
92 |
Fugi Chem. Ind. |
Neusilin A B |
93 |
Chattem Drug
& Chem. Co. |
Dihydroxyaiuminum
Sodium Carbonate |
94 |
Chattern Drug
& Chem. Co. |
Algyn &
Dihydroxyaiuminum Aminoacetate |
95 |
Wyeth |
Aludrox Amphojel A-M-T Basaljel Phosphajel |
95 |
UDGA Inc. |
UDGA tablets |
95 |
Reid Provident
Labs. |
Eugel tablets
susp. |
95 |
Miles |
Riopan Gel. |
96/98 |
Miles |
Alka - 2 |
99 |
Vitaminerals
Inc. |
VM # 21 |
100 |
Wyeth Lab. |
Aludrox etal |
101 |
Tutag Co. S.J. |
Escot capsules |
102 |
Dr. Lamar |
Silicates |
103 |
Mithchum-Thayer
Inc. |
Amitone
tablets |
103 |
Ayerst |
Riopan |
104 |
Forest Labs
Inc. |
Mucogel O.C. Muco-25 |
105 |
Mallinckrodt |
Krem |
106 |
Tutag Co. |
Escot Capsules |
107 |
UpJohn Co. |
Malcotabs Malcogel |
108 |
UpJohn Co. |
Anachloric A
tablets |
109 |
Beecham |
Tartrates |
110 |
UpJohn Co. |
Citrocarbonate |
Amended
-- 9/72
020001
ANTIMICROBIAL
DATA SUBMISSIONS
VOLUME # |
COLOR |
COMPANY |
|
1-8 |
Brown (or
clear) |
Givuidan Corp. |
G-l
(hexachlorophene) |
9-13 |
Green |
Sterling Drug |
Zephiran
Aqueous and Zobenol Aqueous |
14 |
Green |
Sterling Drug |
Soapure and
Sarene |
15 |
Green |
Sterling Drug |
Mediquick |
16 |
Green |
Sterling Drug |
Roccal |
17-18 |
Green |
Sterling Drug |
Benzalkonium
Chloride |
19-20 |
Green |
Sterling Drug |
Hexachlorophene |
21 |
Green |
Sterling Drug |
Zephiran
Tincture and Zobenol Tincture |
22 |
Green |
Sterling Drug |
Campho-Phenique |
23-28 |
Green |
Sterling Drug |
PhisoHex,
Fisohex and Phiso Scrub |
29 |
Green |
Sterling Drug |
Zephiran
Towellettes |
30 |
Black |
Chesebrough-Ponds
Inc. |
Vaseline First
Aid Carbolate Petrolium Jelly |
31 |
Grey |
Monsanto |
Trichlocarban
in bar soap |
32 |
Blue |
R. Schattner
Co. |
Phenolic
Compounds |
33-40 |
Black |
Ciba-Geigy |
Irgasan DP-300 |
41-43 |
Brown |
|
Unguentine |
44-46 |
Black |
Armour Dial
Inc. |
Hexachlorophene
and Trichlocarbon |
47 |
Red |
Vestal Labs |
Septisal |
48 |
Red (or Blue) |
Fine Organics
Inc. |
Temasept (Tribromsalan) |
49 |
Grey |
Campana Corp. |
Cuticura
Medicated Soap |
50 |
Grey |
Rilox Co. |
|
51 |
Black |
Colgate
Palmolive |
Wash’n Dri
Washkins for Babies |
52 |
Black |
Colgate
Palmolive |
Washkins
(hospital pack) |
53 |
Black |
Colgate
Palmolive |
Wash’n
Dri (professional) |
54 |
Black |
Colgate
Palmolive |
Dermassage
Lotion |
55 |
Black |
Colgate
Palmolive |
Tackel Gel |
56 |
Black |
Armour Dial |
Tribrosalan |
57 |
Black |
Smith, Kline
and French |
Pragmatar |
58 |
Black |
Smith, Kline
and French |
Acnomel Cream,
Cake |
59 |
Blue |
Nitine Inc. |
Nitex |
60 |
Clear |
|
Hexachlorophene |
61 |
Brown |
Anti-infective
Literature Search, |
FDA Library |
62 |
Brown |
Ayerst
Laboratories |
Dermoplast
Aerosol |
63 |
Clear |
Defense Med.
Purchase Descriptions-Detergent |
Providene
Iodine |
64 |
Brown |
|
MD-7, Tomac,
Luron |
65-66 |
Brown |
Miscellaneous
Submissions |
|
67 |
Brown |
Ferro Corp. |
Ottasept |
68 |
Tan |
Phenix |
Phenix
Fungicide |
69-70 |
Blue |
Armour Dial |
Hexachlorophene |
71 |
Red |
West Chemical |
Iodophers |
Amended---9/72
ANTIMICROBIAL
DATA SUBMISSIONS
VOLUME # |
COLOR |
COMPANY |
|
1-8 |
Brown (or
clear) |
Givuidan Corp. |
G-l
(hexachlorophene) |
9-13 |
Green |
Sterling Drug
Inc. |
Zephiran
Aqueous and Zobenol Aqueous |
14 |
Green |
Sterling Drug |
Soapure and
Sarene |
15 |
Green |
Sterling Drug |
Mediquick |
16 |
Geen |
Sterling Drug |
Roccal |
17-18 |
Green |
Sterling Drug |
Benzalkonium
Chloride |
19-20 |
Green |
Sterling Drug |
Hexachlorophene |
21 |
Green |
Sterling Drug |
Zephiran
Tincture and Zobenol Tincture |
22 |
Green |
Sterling Drug |
Campo-Phenique |
23-28 |
Green |
Sterling Drug |
PhisoHex,
Fisohex and Phiso Scrub |
29 |
Green |
Sterling Drug |
Zephiran
Towellettes |
30 |
Black |
Chesebrough-Ponds
Inc. |
Vaseline First
Aid Carbolate Petrolium Jelly |
31 |
Grey |
Monsanto |
Trichlocarban
in bar soap |
32 |
Blue |
R. Schatttner
Co. |
Phenolic
Compounds Oraderm lip Lotion Chloraderm Liquid |
33-40 |
Black |
Ciba-Geigy |
Irgasan DP-300 |
41-43 |
Brown |
|
Unguentine |
44-46 |
Black |
Armour Dial
Inc. |
Hexachlorophene
and Trichlocarban |
47 |
Red |
Vestal Labs Dis Chemical Corp |
Septisol |
48 |
Red (or Blue) |
Fine Organics
Inc. |
Temasept
(Tribromsalan) |
49 |
Grey |
Campana Corp. |
Cuticura
Medicated Soap |
50 |
Grey |
Rilox Co. |
|
51 |
Black |
Colgate
Palmolive |
Wash’n Dri
Washkins for Babies |
52 |
Black |
Colgate
Palmolive |
Washkins
(hospital pack) |
53 |
Black |
Colgate
Palmolive |
Wash’n Dri
(professinal) |
54 |
Black |
Colgate
Palmolive |
Dermassage
Lotion |
55 |
Black |
Colgate
Palmolive |
Tackel Gel |
56 |
Black |
Armour Dial |
Tribromsalan |
57 |
Black |
Smith, Kline
and French |
Pragmatar |
58 |
Black |
Smith, Kline
and French |
Acnomel Cream,
Cake |
59 |
Blue |
Nitine Inc. |
Nitex |
60 |
Clear |
Disconsolidated
Food Corp |
Hexachlorophene |
61 |
Brown |
Anti-infective
Literature Search |
FDA Library |
62 |
Brown |
Ayerst
Laboratories |
Dermoplast
Aerosol |
63 |
Clear |
Defense Med.
Purchase Descriptions |
Detergent,
Providone, Iodine |
64 |
Brown |
|
MD-7, Tomac,
Luron |
65-66 |
Brown |
Miscellaneous
Submissions |
|
67 |
Brown |
Ferro Corp. |
Ottasept |
68 |
Tan |
Phenix |
Phenix
Fungicide |
69-70 |
Blue |
Armour Dial |
Hexachlorophene |
71 |
Red |
West Chemical |
Iodophors |
72 |
Brown |
Chesebrough
Ponds Inc. |
Virac Topical
Germacide |
73 |
Tan |
R.T.
Vanderbilt |
Vancide |
74-76 |
Brown |
Plough Inc. |
Solarcaine |
77-79 |
Brown |
Plough Inc. |
Maxana
Medicated Powder |
80-82 |
Blue |
Merck, Sharp
& Dohme |
ST 37
Antiseptic |
83 |
Black |
Proctor and
Gamble |
Safeguard |
84 |
Brown |
C.R. Canfield
& Co. |
Sebacide |
85 |
Tan |
High Chemical
Company |
Klorlyptus |
86 |
Blue |
Merck, Sharp
& Dohme |
Approve |
87-91 |
Black
(looseleaf) |
Miles Labs |
Bactine |
92 |
Clear |
C.R. Canfield |
Sebacide |
93 |
Black |
UpJohn Co. |
Mercresin |
94 |
Brown |
Plough, Inc. |
Clean’n Treat |
95 |
Clear |
Marika |
Verdi Lotion |
96 |
Clear |
Armour Dial |
Dial and
Safeguard Supp. |
97 |
Clear |
Sterling Drug |
PhisoHex |
98 |
Brown |
Purdue
Frederick |
Betadine
Cleanser |
99 |
Brown |
Purdue
Frederick |
Betadine
Antiseptic |
100 |
Brown |
Purdue
Frederick |
Betadine
Aerosol Spray |
101 |
Brown |
Purdue
Frederick |
Betadine
Ointment |
162 |
Brown |
Sterling DRUG |
Tribromosalicylanilide |
103 |
Brown |
Armour Dial,
Inc. |
Hexachlorophene |
104 |
Brown |
CIBA-GEIGY |
Irgasan DP 300 Triclosan |
105 |
Brown |
Pfister |
Tribromosalicylanilide |
106 |
Brown |
FDA Literature
Search Supplement #1 |
Dichloro-m-Xylenol O-Phenyl-Phenol Pyrithione
Zinc |
107 |
Blue |
Lever Brothers |
Tribromsalan |
108-113 |
Red or Yellow |
Lever Brothers |
Tribromsalan |
114 |
Yellow (3 copies
only) 1. Mrs. Bruch 2. Dr. Epstein 3. Dr. Kinoshita |
Lever Brothers |
Tribromsalan |
115 |
Blue |
FDA Literature
Search Supplement #2 |
Quaternary
Ammonium Compounds |
116 |
Clear |
Ciba Geigy |
Irgasan DP-300 |
117 |
Black |
Colgate |
P-300 Soap Bar |
118 |
Black |
Colgate |
P-300 Soap Bar |
119 |
Blue |
Purdue
Frederick |
Betadine
Providone-iodine |
120 |
Black |
Sherwin
Williams |
Tribromosalicylanilide |
121 |
Blue |
Merck, Sharp
& Dohme ( |
5-Chloro-2
(2.4 Dichloro-Phenoxy) Phenol |
122 |
Yellow or Red |
Lever Brothers |
Tribromsalan |
123 |
Black |
Armour Dial
Inc. |
Triclocarban
Summary Report |
124 |
Black |
Armour Dial
Inc. |
Triclocarban
Raw Data |
125 |
|
|
3 Volumes
combined in one |
126 |
Brown |
Armour Dial
Inc. |
Jacket (except
Dr. Kinoshita’s) |
127 |
Brown |
Armour Dial
Inc. |
Triclocarbon |
128 |
Black |
Parke Davis |
Benzethonium
Chloride (Phemerol) |
129 |
Clear |
Smith, Kline
& French |
Pragmator
(Labeling Change) |
130 |
Clear |
FDA |
FDA Health
Practices and Opinions Study |
131 |
Yellow |
West Chemical |
Ionol (BHT) |
132 |
Yellow |
Fine Organics
Inc. |
TBS |
133 |
Clear or Clear |
Proctor &
Gamble |
1972-73
Antibacterial animal studies Preliminary
Report TCC, TFC, BSA, HCP |
134 |
Green |
Sterling Drug |
Zephiran Cl. |
135 |
Gray |
|
Unquentine |
136 |
Blue |
Sterling Drug |
Tribromo
Salicylanilide |
137 |
Blue |
Sterling Drug |
Tribromo
Salicylanilide |
138 |
Green |
FDA Literature
Search Supplement #2 (abstracts) |
Quaternary
Ammonium Compound |
139 |
Brown |
Procter &
Gamble |
91 Day, Rat
Feeding Study with HCl, TBS, TCC, TFC |
140 |
Gray |
West Chemical |
Iodophors |
141 |
Gray |
lCl |
Hibitane
(chlorhexidine Gluconate) submission dated 10-13-72 to BD-120 |
142 |
Black |
CIBA-GEIGY |
Irgasan DP-300 |
143 |
Gray |
Sterling Drug |
Methylbenzethonium
chloride |
144 |
Red |
FDA |
Article on
“Triple Dyd” (Dr. Lockhart) |
145 |
Gray |
Chesebrough
Pond, Inc. |
Addendum to
VIRAC |
146 |
Black |
Rystan |
Sodium
Propioxiate Chlorophyll |
147 |
Gray |
R. Schattner
Company |
(Prophyllin)
Chloraderm (invivo data) |
148 |
Yellow |
Procter &
Gamble Company |
28 Day Rabbitt
Study HCP, BSA, TCC, TFC |
149 |
Yellow |
Jerry M. Rice,
Ph.D Ncl |
Letter to Dr.
Francis Margulli, FDA Toxicity & Carcinogenicity of PVP |
150 |
Yellow |
Peter S.
Herman, MBBS, MSC, CSPR; |
Letter to Mary
Bruch Executive Secretary, OTC Panel |
151 |
Yellow |
Sterling Drug
Inc. |
Individual
Brain Weights of rats TBS Study |
152 |
Yellow |
Chesebrough
Ponds, Inc. |
Virac
Supplemental Information (New PDR Section) |
153 |
Black |
Ciba-Geigy
Corp. |
Irgasan CF3
Cloflucarban Additional Safety Data |
154 |
Black |
Ciba-Geigy
Corp. |
Iragasan CF3
Cloflucarban Additional Safety Data |
155 |
Yellow |
Colgate-Palmolive
Company |
Letter to
Panel Chairman re: TBS |
156 |
Various Colors |
Ferro Corp. |
Additional
test data on Otrasept |
157 |
Red |
West Chemical |
Additional
data on Iodophors |
158 |
Blue |
FDA |
Cross Index to
Submission |
159 |
Clear (and
Blue) |
The Purdue
Frederick Co. |
Additional
Data on Betadine |
160 |
Clear |
Ferro Corp. |
Additional
Data on p-chloro-xylenol |
161 |
Red |
West Chemical
Products Inc. |
Additional
Data on Iodophors |
162 |
Brown |
Huntington
Laboratories Inc. |
Iodophors |
163 |
Brown |
Sterling Drug
Inc. |
Additional
Data on TBS |
164 |
Yellow |
Letters from
various dermatologists |
re: TBS |
165 |
Brown |
Monsanto |
TCC |
166 |
Black |
Ciba-Geigy
Corp. |
Iragasan (CF
3) Additional Data |
167 |
Black |
Ciba-Geigy
Corp. |
Iragasan (DP
300) Additional Data |
168 |
Black |
Ciba-Geigy
Corp. |
Iragasan (DP
300) Additional Data |
169 |
Red |
Lever Brothers
Co. |
TBS Additional
Data |
170 |
Blue |
Lever Brothers
Co. |
Irgasan (DP
300) |
171 |
Yellow |
|
Comments on
Proposed Definitions and Guidelines |
172 |
Brown |
Fine Organics |
TBS Additional
Data (Summary) |
173 |
Clear |
Fine Organics |
TBS Additional
Data |
174 |
Blue |
|
Phisohex-Final
Report Infant Monkey Study |
175 |
Black |
Chesebrough-Ponds,
Inc. |
Additional
Data; Vasoline Carbolated Petroleum Jelly |
176 |
Blue |
W. Mitchel Sams, Jr., M.D. Prof. And Head Division of Dermatology University of |
Letter
regarding TBS |
177 |
Blue |
West Chemical
Products, Inc. |
Comments on
Panels Proposed Definitions |
178 |
|
FDA |
Misc. Reports
(Proctor and Gamble NDA) |
179 |
|
Onyx Chemical
Company |
Toxicity data
on Quaternary Ammonium Compounds |
180 |
Yellow |
Colgate-Palmolive |
Additional
data on Dermassage - Comments on Oxyquinoline Sulfate as an active ingredient |
181 |
Red |
West Chemical
Products, Inc. |
Iodine
Bibliography |
182 |
Black |
Colgate-Palmolive |
Additional
animal safety data on Irgasan, HCP & TBS |
183 |
Black |
Colgate-Palmolive |
|
184 |
Black |
Colgate-Palmolive |
|
185 |
Black |
Colgate-Palmolive |
|
186 |
|
|
Misc. FDA
Reports |
187 |
|
Fine Organics |
90 Day
Subacute Rat Study on TBS |
188 |
|
Bristal-Myers
Co. |
Presentation
on Skin Antiseptics |
189 |
|
Monsanto |
TCC
Reproduction Study |
190 |
|
FDA |
Additional
data on Phenol |
191 |
|
FDA |
Misc. Uncited
Ref. |
Topical Antimicrobial Drug Products for OTC
Human Use Establishment of a Monograph and Reopening of Administrative Record
Docket No.
75N-0183
Volume
02APA1
In the FEDERAL REGISTER of September 7, 1982 (47
FR 39406), the administrative record for the OTC topical antimicrobial drug
products rulemaking was reopened to include a statement on OTC Drug Products
for the Treatment of Diaper Rash by the Advisory Review Panel on OTC
Miscellaneous External Drug Products. To
avoid duplication, the Public Administrative File for that statement appears as
part of the administrative file for the OTC external analgesic drug products
rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982
(47 FR 39412).
The material included in the topical antifungal
rulemaking is identified in OTC Volume 06BPA6 in the external analgesic
administrative file.
DATA AND INFORMATION
Volume |
Submittted by |
Trade Name |
Ingredients Listed |
030001 |
Plough, Inc. |
|
Aspirin |
030002 |
Plough, Inc. |
|
Aspirin |
030003 |
A.H. Robins
Co. |
Arthralgen
Tablets |
Sallcylamide Acetaminophen |
030004 |
A.H. Robins
Co. |
Pabalate
Tablets |
Sodium
Sallcylate (PABA) Sodium Aminobenzoate |
030005 030006 030007 |
Warner Lambert
Co. |
Bromo Seltzer |
Acetaminophen Phenacetin Potassium
bromide Caffeine Sodium
bicarbonate Citric acid |
030008 to 030015 |
Miles
Laboratories Inc. |
Alka-Seltzer |
Aspirin Mono-calcium
phosphate Sodium
bicarbonate Citric acid |
030016 to 030029 |
McNeil
Laboratories, Inc. |
Tylenol
Tablets |
Acetaminophen |
030030 to 030032 |
McNeil |
Tylenol Elixir |
Acetaminophen |
030033 to 030035 |
McNeil |
Tylenol
Chewable Tablets |
Acetaminophen |
030036 |
McNeil |
Tylenol Drops |
Acetaminophen |
030037 |
Abbott
Laboratories |
Children’s
Chewable Tab. |
Aluminum
Aspirin |
030038 |
Smith Kline & French Lab. 15000 Spring Carden
St. |
Ecotrin,
enteric coated |
Aspirin |
030039 |
The Dow
Chemical Co. |
Tenlap Elixir |
Acetaminophen |
030040 |
The Dow
Chemical Co. |
Phensal
Tablets |
Aspirin Phenacetin Caffeine |
030041 |
Plough, Inc. |
Aspergum |
Aspirin |
030042 |
Warren-Teed
Pharm. Inc. |
Magan Tablets |
Magnesium
Salicylate |
030043 |
Whitehall Laboratories Inc. |
Duplexin
Tablets |
Dihydroxy
Aluminum Sodium Carbonate Magnesium
Carbonate Aspirin Phenacetin Caffeine |
030044 |
Whitehall Labs
Inc. |
Arthritis Pain
Formula |
Micronized
Aspirin Dried Aluminum
Hydroxide gel Magnesium
Hydroxide |
030045 |
|
Anacin |
Aspirin Caffeine |
030046 |
|
Saloxium
Tablet |
Salicylsalicylic
Acid (Salsalate) |
030047 |
VSV Pharmaceutical Corp. |
Liquiprin
Suspension |
Acetaminophen |
030048 |
USV |
Femicin
Tablets |
Acetaminophen Saliylamide Caffeine Pyrilamine
Maleate Homatropine
Methylbromide |
030049 |
USV |
Comeback
Tablets |
Acetaminophen Salicylamide Caffeine |
030050 |
Dorsey
Laboratories |
Calurin
Tablets |
Calcium
Carbaspirin |
030051 |
Dorsey |
Cama Inlay
Tabs |
Aspirin (10
grains) Magesium
hydroxide Aluminum
hydroxide dried gel |
030052 |
Dorsey |
Chexit Tablets |
Phenylpropanaolamine
hydrochloride Pheniramine
maleate Phrilamine
maleate Dextromethorphan
hydrobromide Terpin hydrate Acetaminophen |
030053 |
Dorsey |
Pabirin
Tablets |
Aspirin Aminobenzomic
acid dried aluminum
hydroxide gel |
030054 |
Dorsey |
Triaminicin
Tablets |
Phenylpropanolamine
hydrochloride Pheniramine
maleate Pyrilamine
maleate Aspirin Acetaminophen Caffeine Ascorbic acid |
030055 |
Dorsey |
Tussagesic
Tablets/Suspension |
Phenylpropanolamine
hydrochloride Pheniramine
maleate Pyrilamine
maleate Dextromethorphan
hydrobromide Terpin hydrate Acetaminophen |
030056 |
Dorsey |
Ursinus Inlay
Tabs |
Calcium
Carbaspirin Phenylpropanolamine
hydrochloride Phyrilamine
maleate |
030057 |
|
Tempra
Drops,Syrup, Tablet |
Acetaminophen (Drops) (Syrup) (Tablets) |
030058 |
Block Drug
Company Inc. |
BC Powder |
Aspirin Salicylamide Caffeine |
|
|
BC Tablet |
Aspirin Salicylamide Caffeine |
030059 |
William H.
Rorer Inc. |
Ascriptin
Tablet |
Aspirin Magnesium
Hydroxide Aluminum
Hydroxide |
030060 |
Monsanto
Industrial Chemicals Co. |
Salicylamide |
(No dosage
form) |
030061 |
Monsanto |
Aspirin |
(No dosage
form) |
030062 |
Monsanto |
Phenacetin |
(No dosage
form) |
030063 |
J. Maxwell
Little, Ph.D. Professor
& Chairman Dept. Of
Pharmacology |
Headache
Powders |
Phenacetin Caffeine Citric acid Potassium
chloride Lactose Aspirin |
030064 |
Sterling Drug
Inc. |
Bayer Aspirin
tablets Bayer
Children’s Aspirin Bayer
Timed-Release Measurin Tablets Cortal para
Ninos Fizrin |
Aspirin Aspirin Aspirin Aspirin Aspirin Aspirin Sodium
Bicarbonate Sodium
Carbonate Citric Acid |
030065 |
|
Mejoral Cafenol Tablet Cafiaspirina
Tablet |
Aspirin Caffeine Aspirin Caffeine Aspirin Caffeine |
030066 |
|
Midol |
Aspirin Cinnamedrin
hydrochloride Caffeine |
030067 |
|
Vanquish |
Aspirin Acetaminophen Caffeine Dried Aluminum
hydroxide gel Magnesium
hydroxide |
030068 |
|
Cope |
Aspirin Caffeine Methapyrilene
fumarate Magnesium
hydroxide Dried Aluminum
hydroxide gel |
030069 to 030072 |
Bristol-Myers
Products |
Bufferin Arthritis Strength Bufferin Excedrin Excedrin P.M. Disolve |
Aspirin Magnesium
Carbonate Dihydroxyaluminum
aminoacetate Aspirin Magnesium
carbonate Dithydroxyaluminum
aminoacetate Aspirin Acetaminophen Caffeine Salicylamide Aspirin Salicylamide Acetaminophen Methapyrilene
fumarate Aspirin Sodium
bicarbonate Powdered
citric acid Monocalcium
phosphate |
030073 |
Sandoz
Pharmaceuticals |
Fiogesic
Tablets |
Calcium carbaspirin Phenylpropanolamine
hydrochoride Pheniramine
maleate Pyrilamine
maleate |
030074 |
E.R. Squibb
& Sons Inc. |
Aspirin
Tablets Trigesic
Tablets Valadol Liquid Valadol
Tablets Valadol
Chewable Tablets |
Aspirin Acetaminophen Caffeine Acetylsalicylic
acid Acetaminophen Acetaminophen Acetaminophen |
030075 |
Templetons
Inc. |
Templeton’‘s
T-R-C’s |
Aspirin Caffeine |
030076 |
Fountain Labs,
Inc. |
PANO |
Aspirin Caffeine |
030077 |
The Purdue
Frederick Co. |
Arthropan
Liquid |
Choline
Salicylate |
030078 |
Federal
Register Notice of April 20, 1972 and NAS/NRC
Reports |
Surfacaine
Suppositories Bufferin
Tablets Trigesic
Tablets Nebs Tablets Apamide
Tablets Metalid
Tablets Duplexin
Tablets Nysacetol
Tablets Tylenol Elixir Tempra Drops, Syrup Tralgon Elixir Tylenol
Tablets Arthropan
Liquid Actasal
Pediatric Drops Defencin
Tablets |
Cyclomethycaine Aspirin Aluminum
Glycinate Magnesium
Carbonate Acetaminophen Aspirin Caffeine Acetaminophen Acetaminophen Acetaminophen Dihydroxyaluminum
Sodium Carbonate Magnesium
Carbonate Aspirin Phenacetin Caffeine Acetaminophen Acetaminophen Acetaminophen Acetaminophen Acetaminophen Choline
Salicylate Choline
Salicylate Glycerylguaiacolate
Aspirin Phenyltoloxamine
Dihydrogen Citrate |
030079 |
The Upjohn
Company |
Aspirin
Tablets |
Aspirin |
030080 |
|
P-A-C Compound
Tablets, Capsules |
Phenacetin Aspirin Caffeine |
030081 |
|
Acetonyl
Effervescent Salt |
Aspirin |
030082 |
|
Salicionyl
Effervescent Salt |
Sodium
Salicylate Sodium
Bicarbonate |
030083 to 030086 |
Warner-Chilcott
Laboratories |
Sinutab |
Acetaminophen Phenacetin Phenylpropanolamine
HCl Phenylpropanolamine
Citrate |
|
|
Sinutab ll |
Acetaminophen Phenacetin Phenylpropanolamine
HCl |
030087 030088 to 030090 |
Norwich
Pharmacal Co. |
Aspirin Nebs Tablets Nebs Elixir |
Aspirin Acetaminophen Acetaminophen |
030091 (labels
only) |
Eneglotaria
Medicine Co. of Pureto Rico |
Pediascirin
Syrup |
Acetaminophen |
|
L.W. Estes
Co., Inc. |
Estes Nu-Ral
Tablets |
Aspirin Caffeine |
|
The Rilox Co. |
Baltar’s
Medium |
Sodium
Salicylate Potassium
Iodide Cascara
Sagrade |
|
R.L. Gaddy Pharmacist |
EZ-IT Tablets |
Aspirin Phenacetin Caffeine |
030092 |
McMurray &
Pendergast for Cooper Labs. Inc. |
Persistin |
Salicylsalicylic
acid Aspirin |
030093 (labels
only) |
Curtis Drug
Co. |
Curtis A-R Pain Relief |
Sodium
Sallcylate Sodium Vitamin C
(Ascorbic Acid) Vitamin B
(Thiamin Hydrochloride) Vitamin B
(Riboflavin) |
|
Berry &
Withington Co. |
Sodium
Salicylate Aspirin Buffered
Aspirin Aspirin
Compound No.2 |
Aspirin Glycline,
Aluminum Hydroxide Magnesium
Carbonate Aspirin Penacetin Caffeine |
030093 (cont.) |
Republic Drug
Co. |
A.P.C. Tablets |
Aspirin Phenacetin Caffeine |
|
|
A.P.C. with
Codeline Aspirin Buffered
Aspirin Superin Tapanol |
Aspirin Phenacetin Caffeine Codeine
Phosphate Aspirin Aluminum Hydroxide Glycine Magnesium
Carbonate N-Acetyl-p-aminophenol Salicylamide Aspirin Caffeine Acetaminophen |
|
Boericke &
Tafel |
Boericke &
Runyon Tablets No. 200 |
Acetanilid Caffeine Sodium
Bicarbonate Calomel Iris
Versicolor Nux Vomica |
|
Boericke &
Tafel |
B & R Tablet
No. 171A |
Henatyne
(represents Acetylsalicylic 1/10 gr. And Magnesium Oxide 2/10 gr.) Acetylsalicylic
Acid Macrotin Bryonin |
|
Lewis’ Mfg.
Co. |
Dr. Lewis’
Preparation for Rheumatism |
Sodium
Salicylate |
030094 |
Prepared bt
Lee M. Quon, OTC Staff |
Comparative
Toxicity of Phenacetin and Acetaminophen |
|
030095 |
Miles
Laboratories |
Prepared by
Allen R. Cooke, M.D. The Role of
Acid in the Pathogenesis of Aspirin Induced Gastronintestinal Erosions and
Hemorrhage |
|
030096 |
T.E. Watson
Co. American
Felsol Co. Division |
Felsol Powders Felsol Tablets |
Antipyrine Iodopyrine Citrated
Caffeine |
030097 |
Edgar Larsen |
|
Acetanilid Caffeine Sodium
Bicarbonate |
030098 |
T.E. Watson
Co. |
|
Antipyrine |
030099 |
T.E. Watson
Co. |
|
Antipyrine |
030100 |
T.E. Watson
Co. |
|
Antipyrine |
030101 |
T.E. Watson
Co. |
|
Antipyrine |
030102 |
Sterling Drug
Inc. |
Vanquish
addition |
Acetaminophen
literature |
030103 |
Bristol-Myers
Co. |
Remarks
concerning the safety and effectiveness of Caffeine in combination with
aspirin-order analgesic with special reference to Excedrin |
|
030104 |
Miles
Laboratories Inc. |
Alka
Seltzer-Safety And Effectiveness of a Buffered Sodium Acetylsalicylate
Solution |
|
030105 to 030112 |
Miles
Laboratories Inc. |
References for
Volume 030104 |
|
030113 |
Bristol-Myers
Products |
Presentation
to the Panel on Bufferin and Excedrin |
|
030114 and 030115 |
Bristol-Myers
Products |
Excedrin P.M. |
Aspirin Salicylamide Acetaminophen Methapyrilene
Fumarate |
030116 |
Plough, Inc. |
Aspergum -
Additional data |
|
030117 |
Bristol-Myers
Products |
Duration of
Action Bufferin compared to standard aspirin |
|
030118 |
Plough, Inc. |
Aspergum -
additional data #2 |
|
030119 |
Smith Kling
& French Laboratories |
Ecotrin -
additional data |
|
030120 |
T.E. Watson
Co. |
Felsol
(Additional Data) |
Antipyrine |
030121 to 030124 |
Miles
Laboratories |
Alka-Seltzer (Additional
Data) |
|
030125 to 030127 |
|
Anacin Arthritis Pain
Formula (Additional
Data Prepared by Clinical Resources, Inc.) |
|
030128 |
McNeil
Laboratories, Inc. |
Acetaminophen |
Acetaminophen
(additional data) |
030129 |
|
Additional
data |
Micronized
Aspirin |
030130 |
Ciba-Geigy
Corp. |
General
Comments on Buffered Analgesics |
|
030131 |
Endo
Laboratories, Inc. |
Percogesic Dilone |
Acetaminophen Phenyltoloxamine
citrate Acetaminophen Phenyltoloxamine
citrate Caffeine |
030132 |
Miles Labs.,
Inc. |
References for
Alka-Seltzer |
|
030133 |
Sterling Drug
Inc. |
Additional
Information |
|
030134 |
Burroughs
Wellcome Co. |
Additional
Information |
|
030135 |
Warner-Lambert
Res. Inst. |
Additional
Information on Bromo-Seltzer |
Acetaminophen Sodium bicarbonate Citric Acid |
030136 to 030138 |
Bristol-Myers
Products |
Bufferin |
Additional
information |
030139 |
Bristol-Myers
Products |
Bufferin |
Additional
Information |
030140 |
Eli Lilly
& |
Aspirin
Suppositories |
Aspirin |
030141 |
Glenbrook
Laboratories, Division of Sterling Drug, Inc. |
Information on
Acetaminophen |
|
030142 |
Plough, Inc. |
Additional
inforamtion on St. Joseph Aspirin for Children |
|
030143 and 030144 |
American Home
Products and Bristol-Myers
Products |
Joint
presentation to the 24th Panel meeting “arthritis in the label” |
|
030145 |
T.E. Watson
Co. |
Felsol Powder
and Tablet |
additional
information |
030146 |
S.B. Penick
& Co. |
Salicylamide
bibliography |
|
030147 |
Miles
Laboratories Inc. |
Additional
data on Alka-Seltzer |
|
030148 |
Bristol-Myers
Products |
|
|
030149 |
Sterling Drug
Inc. |
Dr. Fallier’s
presentation on 9/25/74 |
|
030150 |
OTC Division |
General data
collection |
|
030151 |
McNeil
Laboratories |
Abstract of
Study by Drs. Cooper and Beaver |
|
030152 |
Reprints and
bibliography on analgesic nephropathy |
|
|
030153 |
Bristol-Myers |
Excedrin |
Additional
data |
030154 |
Endo |
Percogesic |
Acetaminophen |
030155 |
|
|
phenyltoloxamine |
030156 |
|
Saloxium, |
additional
data |
030157 |
Warner-Lambert
Company |
Bromo-Seltzer |
additional
data |
030158 |
Glenbrook
Laboratories Division of Sterling Drug, Inc. |
Information,
and reprints, on aspirin |
|
030159 |
Primer on the
Rheumatic Diseases, Prepared by a Committee of the American Rheumatism
Association Section of the Arthritis Foundation, 1973 |
|
|
030160 |
Bristol-Myers |
Neolin |
Aspirin Magnesium
carbonate Calcium
carbonate |
030161 |
McNeil
Laboratories, Inc. |
Acetaminophen |
Pediatric dose
comments, data |
030162 |
Miles
Laboratories, Inc. |
Alka-Seltzer |
Additional
information |
030163 |
Endo
Laboratories, Inc. |
Percogesic |
Additional
information |
030164 |
Burroughs
Wellcome Co. Block Drug
Co., Inc. The
Proprietary Assn. Plough, Inc. Vick Divisions
Reseach/Vick Chemical Co. Bristol-Myers
Products |
|
|
030165 |
Endo
Laboratories |
Percogesic |
additional information presented at the November
22, 1976 meeting. |
030166 |
Glenbrook
Laboratories, Division of Sterling Drug, Inc. |
|
|
030167 |
Miles
Laboratories, Inc. |
|
|
030168 |
American Home
Products Corp. |
|
|
030169 |
Various
memoranda of discussions and evaluations of Percogesic |
|
|
030170 |
Miles
Laboratories |
|
Supplemental
Data on Alka-Seltzer, dated October 30, 1974, Master List of References |
030171 |
|
|
|
030172 |
Negative
responses to request for data--38 companies |
|
|
030173 |
Summary
minutes of Panel meetings #1-#28 |
|
|
030174 |
Bibiography,
1972 compiled by FDA Medical Library |
|
|
030175 |
FDA-OTC
Literature Search |
Abstract
Bibiography |
Aspirin, 1972 |
030176 |
FDA-OTC
Literature Search |
Abstract
Bibliography |
Phenacetin,
1972 |
030177 |
FDA-OTC
Literature Search |
Abstract
Bibliography |
Caffeine, 1972 |
030178 |
FDA-OTC
Literature Search |
Abstract
Bibliography |
Internal
Analgesics other than aspirin, phenacetin, caffeine, 1972 |
030179 |
Federal Trade
Commission |
Comments on
preliminary Draft #6 |
|
030180 |
The Propietary
Association, position statement for discussion of labeling at the August
21-23, 1976 meeting |
|
|
030181 |
Various
Submissions, Memoranda, etc. regarding aspirin, phenacetin |
|
|
030182 |
Various
Submissions, Memoranda, etc. regarding acetaminophen, antipyrine, caffeine |
|
|
CCABA SUBMISSION CHART
Volume Number |
Submittor |
Subject |
040001 to 040004 |
Merck Chem.
Division Thomas Davis |
Noscapine |
040005 |
Chesebrough-Ponds |
Pertussin |
040006 to 040009 |
McNeil
Laboratories Patrick H.
Seay, Ph.D. |
Co-Tylenol
Cold Formula Tablets |
040010 |
Monsanto |
Methapyrilene
Hcl |
040011 |
Creomulsion
Co. |
Creomulsion |
040012 to 040018 |
Pennwalt |
Allerest |
040019 |
Smith Kline
& French |
Ornex |
040020 to 040021 |
Smith Kline
& French |
Benzedrex |
040021 |
Smith Kline
& French |
Ornacol |
040022 |
Ludens |
Cough Drops |
040023 to 040025 |
Calgon
Consumer Products Jane Howell |
Sucrets |
040026 |
A.H. Robins
Co. Robitussin |
Glyceryl
guaiacolate |
040027 |
Pennwalt |
Sinarest
Tablets |
040028 |
|
|
040029 to 040046 |
Johnson &
Johnson |
Sine-aid |
040032 |
USV
Pharmaceutical Corp. |
Liquiprin |
040047 to 040055 |
Vicks Chemical
Co. |
Nyquil Nighttime
Cold Medicine |
040056 to 040060 040060A |
Vicks Chemical
Co. |
Vicks Vapor
Rub |
040061 to 040063 |
Vicks Chemical
Co. |
Vicks Cough
Drop |
040063 |
USV
Pharmaceutical Corp. |
Vaponefrin/Asthmanefrin |
040064 |
Vicks Chemical
Co. |
Vicks Cough
Syrup |
040065 to 040066 |
Vicks Chemical
Co. |
Vick Inhaler |
040067 |
Vicks Chemical
Co. |
Vick Cough
Silencer Formula 44D
Cough Syrup |
040068 |
Vicks Chemical
Co. |
Formula 44D
Cough Syrup |
040069 to 040070 |
Vicks Chemical
Co. |
Sinex Nasal
Spray |
040071 to 040072 |
Vicks Chemical
Co. |
Formula 44D
Cough Discs |
040073 to 040079 |
Vicks Chemical
Co. |
Formula 44
Cough Mixture |
040080 |
Father John
Medicine Gerald Donehue |
Cough Syrup |
040081 to 040083 |
Schering Corp. Ken Brilhart |
Coricidin Chlor-Trimeton Afrin |
040084 |
Hoffman-LaRoche |
Romilar Syrup |
040085 |
Hoffman-LaRoche |
Romilar
Expectorant |
040086 |
Hoffman-LaRoche |
Romilar HB
Tablets |
040087 |
Hoffman-LaRoche |
Romilar CF
Syrup |
040088 |
Hoffman-LaRoche |
Romilar CF
Capsules |
040089 |
Hoffman-LaRoche |
Romilar Cough
and Cold Capsules |
040090 |
Hoffman-LaRoche |
Children’s Romilar
Syrup |
040091 |
Hoffman-LaRoche |
Romilar CF
8-Hr. Syrup |
040092 |
Hoffman-LaRoche |
Romilar Cough
Discs |
040093 |
Hoffman-
LaRoche |
Romilar
Chewable Cough Tablets |
040094 |
Hoffman-LaRoche |
Romilar III |
040095 |
Chesebrough-Ponds |
Pertussin Wild
|
040096 |
Chesebrough-Ponds |
Pertussin
Medicated Vaporizer |
040097 |
Chesebrough-Ponds |
Pertussin Plus
Nighttime Cold Medicine |
040098 |
Knoll Pharm.
Co. |
Verequad |
040099 |
USV
Pharmaceutical Corp. |
Arrestin |
040100 |
USV
Pharmaceutical Corp. |
Vaponefrin/Asthmanefrin |
040102 |
Abbott
Laboratories |
Quelidrine
Cough Syrup |
040103 |
Abbott
Laboratories |
Calcidrine
Syrup |
040104 |
A.H. Robins
Co. |
Robitussets
Troches |
040105 |
A.H. Robins
Co. |
|
040106 |
A.H. Robins
Co. |
Robitussin DM
Syrup |
040107 |
Ciba-Geigy
Corp. |
Otrivin Nasel
Solution and Spray |
040108 |
LaWall &
Harrison Donald Abbott |
Troutman’s
Cough Syrup |
040109 |
The Dow
Chemical Co. |
2/G |
040110 |
The Dow
Chemical Co. |
Novahistine-Elixir |
040111 |
The Dow
Chemical Co. |
Novahistine |
040112 |
The Dow
Chemical Co. |
2 G/DM |
040113 |
The Dow
Chemical Co. |
Novahistine
Expectorant |
040114 |
The Dow
Chemical Co. |
Novahistine -
Special Study Addendum |
040115 |
The Dow
Chemical Co. |
Novahistine
Fortia |
040116 |
Ives Labs.
Inc. |
Cerose DM |
040117 |
Ives Labs.
Inc. |
Cerose |
040118 |
The
Mentholatum Co. |
Mentholatum
Ointment |
040119 |
|
Dondrill
Anticough Tablets |
040120 |
|
Dristan
Capsules |
040121 |
|
Primatene
Asthma Tablets (P) |
040122 |
|
Primatene
Asthma Tablets (M) |
040123 |
|
Dristan Nasal
Mist and Vapor Spray |
040124 |
|
Clear and dry
Tablets |
040125 |
|
Dristan Cough
Formula Liquid |
040126 |
|
Dristan
Decongestant Tablets |
040127 |
|
Primetime and
Bronitin Mist |
040128 |
|
Bronitin
Tablets |
040129 |
Ives Labs.
Inc. |
Cerose Compond |
040130 |
Ives Labs.
Inc. |
Cetro-Cirose |
040131 |
Warner-Lambert
Co. |
Listerine
Cough Control Lozenge |
040132 |
Warner-Lambert
Co. |
Super Anahist
Decongestant Nasal Spray |
040133 |
Warner-Lambert
Co. |
Big 4 Cough
Formula |
040134 |
Warner-Lambert
Co. |
Listerine
Antiseptic Lozenge |
040135 |
Warner-Lambert
Co. |
Smith Brothers
Cough Discs |
040136 |
Warner-Lambert
Co. |
Hall’s Cough
Tablets |
040137 |
Warner-Lambert
Co. |
Listerine Cold
Tablets |
040138 |
Warner-Lambert
Co. |
Super Anahist
Decongestant Tablets |
040139 |
Ciba-Geigy |
Privine Nasal
Solution and Spray |
040140 |
The Dow
Chemical Co. |
Novahistine
Melet |
040141 |
Plough, Inc. |
|
040142 to 040146 |
Merck/Calgon
Consumer Products |
Sucrets Cold
Decongestant Formula |
040147 |
Dorsey
Laboratories |
Dorcol
Pediatric Cough Syrup |
040148 |
Dorsey
Laboratories |
Dor-C Tablets |
040149 |
Dorsey
Laboratories |
Chexit Tablets |
040150 |
Dorsey
Laboratories |
Triaminic
Expectorant |
040151 |
Dorsey
Laboratories |
Triaminic
Syrup |
040152 |
Dorsey
Laboratories |
Triaminicin
Nasal Spray |
040153 |
Dorsey
Laboratories |
Triaminicin
Tablets |
040154 |
Dorsey
Laboratories |
Triaminicol
Cough Syrup |
040155 |
Dorsey
Laboratories |
TussagesicR
Tablets and Suspension |
040156 |
Dorsey
Laboratories |
Ursinus Inlay
Tabs |
040157 |
Merck Sharp
& Dohme |
Capsules &
Elixer Propadrine |
040158 |
Merck Sharp
& Dohme |
Capsules &
Elixer Propadrine |
040159 |
Sterling Drug,
Inc. |
Deka Cough
Syrup |
040160 |
Sterling Drug,
Inc. |
Neo-Synephrine
Elixir |
040161 |
Sterling Drug,
Inc. |
Breacol Cough
Medicine |
040162 |
Sterling Drug,
Inc. |
Bronkaid Mist |
040163 |
Sterling Drug,
Inc. |
Breacol with
Prylon Cough Medicine |
040164 |
Sterling Drug,
Inc. |
Synephicol
Cough Syrup |
040165 |
Sterling Drug,
Inc. |
Recindal Cough
Medicine |
040166 |
Sterling Drug,
Inc. |
Bronkotabs Bronkotabs
HAFS Bronkolixer Bronkaid Tabs |
040167 |
Sterling Drug,
Inc. |
NTR, NTZ, NRT
Nose Drops and Nasal Spray |
040168 |
Sterling Drug,
Inc. |
Neo-Synephrine
Nose Drops & Nasal Spray |
040169 |
Sterling Drug,
Inc. |
Neo-Synephrine Asafen Synephricol |
040170 |
FDA Library |
Bibliography |
040171 |
Chesebrough-Ponds |
Pertussin
Cold-Team-24 |
040172 |
Norwich
Pharmacal Co. |
Quadrin |
040173 |
Norwich
Pharmacal Co. |
Elixir Terpin
Hydrate |
040174 |
Norwich
Pharmacal Co. |
Baby Cough
Syrup |
040175 |
Searle Laboratories |
Amodrine |
040176 |
Pfizer Inc. |
Coryban-D
Nasal Spray |
040177 |
Pfizer Inc. |
Coryban-D
Cough Syrup |
040178 to 040189 |
Pfizer Inc. |
Coryban-D Cold
Capsules |
040190 |
The UpJohn Co. |
Cheracol,
Cheracol D Cheracol
Bilingual |
040191 |
The UpJohn Co. |
Orthoxicol
(Orthoxine Cough Syrup) |
040192 to 040193 |
Miles labs. |
Alka Seltzer |
040194 to 040197 |
A.H. robins |
Dimetane
Elixir (Brompheniramine) |
040198 |
The UpJohn Co. |
Pyrroxate Cap.
And Tablets |
040199 to 040200 |
Warner-Chilcott |
Tedral Tedral Anti-H Tedral susp. |
040201 |
UpJohn Co. |
Emeracol |
040202 |
UpJohn Co. |
Terpin Hydrate
and Codeine Elixir |
040203 |
Block Drug Co. |
BC All Clear |
040204 |
Key Pharm.
Inc. M. Friedland |
Key Tusscapine |
040205 |
Sandoz
Pharmaceuticals Div. Of
Sandoz-Wander |
Fiogesic
Tablets |
040206 |
R. Schiffman
Co. |
Astmandor |
040207 |
LaMay’s
Asthmaeze, Inc. |
LaMay’s
Asthmaeze |
040208 |
F & F
Laboratories, Inc. |
F & F
Cough Lozenge |
040209 |
E.R. Squibb
& Sons, Inc. |
Spec-T
Lozenges |
040210 |
Reid Provident
Labs. |
Reidacol
Histelet Syrup, Histalet DM Syrup, PV tussin, Tusstrol, tusotrol DM, Coton
Syrup |
040211 |
Templetons
Incorp. |
RAZ-MAH Greys
Capsules |
040212 |
Holford Co. |
Holfords Inhaler, Indian Chief Inhaler |
040213 |
FDA |
Summary of
Submissions |
040214 |
|
|
040215 |
Colgate-Palmolive
Co. C.H. Costello |
Congestaid RM
Vaporizer |
040216 |
|
|
040217 |
Penick |
Glyceryl
Guaiacolate |
040218 |
Henry Thayer
Co. |
Thayers
Slippery Elm Throat Lozenges |
040219 |
UpJohn Co. |
Hydriodic Acid |
040220 |
UpJohn Co. |
Iodized Lime |
040221 |
UpJohn Co. |
Special
Formula #2 |
040222 |
UpJohn Co. J.A. Jacob,
M.D. |
Cedicol (Cough
Syrup), |
040223 to 040224 |
Parke Davis
& Co. |
Benylin |
040225 |
Federal
Register 18471 |
Revocation of
Codeine Rx exemption |
040226 |
Nat’l Analysts
Inc. |
Summary of
Health Practices |
040227 |
Parke-Davis |
Benylin
Expectorant |
040228 |
Schering Co. |
Afrin Supplement |
040229 |
E.R. Squibb
& Sons Inc. |
Spect-T Throat
Spray Spec-T
Anesthetic Lozenge |
040230 |
Sterling Drug,
Co. |
Addition to
Neo-Snyephrine |
040231 |
Vicks Chemical
Co. |
Inhaler |
040232 |
Schering/Amendment |
Chlor-Trimeton |
040433 |
Smith Kline
& French |
Clorpheniramine |
040434 |
Smith Kline
& French |
Phenylpropanolamine |
040235 |
Creomulsion
Co. V.O. Rankin |
Beechwood
Creosote |
040236 |
Lilly Research
Labs. |
Published
articles re: Histadyl, methapyriline hydrochloride |
040237 |
Chesebrough-Ponds |
Additional
information on Pertussin Med. Vapor |
040238 |
Bristol-Myers |
Safety of
Sympathomimetic Drugs in Children 3-6 years |
040239 |
Smith Kline
& French Cheston
Simmons |
Caramiphen
Edisylate |
040240 |
Pfizer
Pharmaceuticals |
Toclase Syrup |
040241 |
Pfizer
Pharmaceuticals Michael A.
Hospador |
Toclase
Tablets |
040242 |
Menley &
James Labs. Thomas W.
Richards |
Contac |
040243 |
E.R. Squibb
& Sons Charles L.
Kroll |
Spec-T
Anesthetic Lozenges (New
Formula-Revised) |
040244 |
Warner/Chilcott Chris P.
Katsampes, M.D. |
Tedral |
040245 |
Smith Kline
& French Cheston Simmons |
Ornacol Liquid
and Capsules |
040246 |
Sterling Drug,
Inc. B.G. Crouch,
Ph.D. |
Thenfadil |
040247 |
Chesebrough-Ponds Murry Berdick,
Ph.D. |
Pertussin Wild
|
040248 |
Merck Sharp
& Dohme M. Jane
Howell, M.D. |
Sucrets |
040249 |
Merck Sharp
& Dohme M. Jane
Howell, M.D. |
Sucrets |
040250 |
Bristol-Myers
Co. |
Nasel
Decongestant Properties of Phenylpropanolamine |
040251 |
Vick Division
Research Bob West,
Ph.D. |
Concomitancy
of Colds Symptoms |
040251A |
Vick Division
Research Bob West,
Ph.D. |
Patient
Reports |
040252 |
Vick Division
Research |
Topical
Ephedrine |
040253 |
Smith Kline
& French Cheston
Simmons |
Benzedrex
Inhaler Study |
040254 |
Sterling Drug,
Inc. |
Breacol |
040255 |
Vick Division
Research Bob West,
Ph.D. |
Supplemental -
Formula 44 |
040256 |
UpJohn Co. |
Bronchodilators
in Cough |
040257 |
Vick Division
Research Bob West,
Ph.D. |
Vicks Cough
Drops |
040258 |
Chattem Drug
& Chem. Co. J.M. Holbert,
Ph.D. |
Theophylline
sodium glycinate |
040259 |
Smith Kline
& French |
Caramiphen
Edisylate |
040260 to 040263 |
Wyeth Labs. Wm. L.
Langeland |
Phenergan |
040264 |
Vick Chemical
Co. Bob West,
Ph.D. |
Doxylamine
(Decapryn) as an Antihistamine |
040265 |
Parke-Davis L.M. Lueck |
Proposed study
plan for Diphenhydramine Hydrochloride Pseudoephedrine Hydro. |
040266 to 040271 |
Vicks Division
Research John B. Ward |
Vaposteam |
040272 |
Smith Kline
& French Cheston Simmon |
Propylhexedrine |
040273 |
Miles Labs. Alfred S.
Neely, IV |
Phenylpropanolamine |
040274 |
Richardson-Merrell George
Hoffnagle, M.D. |
Doxylamine
Succinate |
040275 |
A.H. Robins F.A. Clark,
Jr. |
Robitussin |
040276 |
UpJohn Co. Jay A. Nadel,
M.D. |
The Role of
Bronchodilators in CCABA Products |
040277 to 040278 |
Warner-Lambert
Co. Richard C.
Brogle |
Safety and
Efficacy Review of OTC CCABA Products, Listerine Antiseptic |
040279 |
Vick/Richardson
Merrell |
Oil of
Turpentine |
040280 |
A.H. Robins F.A. Clark |
Suppl. Subm.
To Clinical report of GG Robitussin |
040281 to 040283 |
Hoffman-LaRoche David Winer |
Phenindomine
tartrate (Thephorin -
Roche) |
040284 |
Ciba-Geigy Edward C.
McKeen, M.D. |
Otrivin
(xylometazoline) (hydrochloride
NF) Nasal Solution and Spray |
040285 |
Miles Labs. Richard
Shupack |
Three Clinical
Salts of Phenylpropanolamine |
040286 |
Wyeth Labs. Dr. D. Shaw |
Antihistaminic
Effectiveness of Promethazine |
040287 |
Proprietary
Association |
Supplemental
Data on Combinations on the Market |
040287A |
Proprietary
Association |
Data on
Combinations on the Market |
040288A 040288B |
Swenson/Behrman |
Phenylephrine
and Phenindamine |
040289 |
Creomulsion
Company V.O. Rankin |
Creomulsion
Cough Medicine |
040290 |
Vicks Division
Research |
Ephedrine as
Intranasal Decongestant |
040291 |
Vicks Division
Research G. F.
Hoffnagle |
Literature on
Xylometazoline |
040292 |
Smith Kline
& french Arthur L.
Davis |
Cold, Cough,
Allergy Bronchodilator & Anti-asthmatic Drugs |
040293 |
Pennwalt Corp. A. Lee
Caldwell |
Nonprescription
drugs Timed Release dosage forms |
040294 |
Smith Kline
& French Phiip
Tannebaum |
Caramiphene
dislyate dosage Propylhexedrine Category I combinations |
040295 |
Vick Division
Reasearch G. F.
Hoffnagle |
Alcohol Vicks NYQUIL |
040296 |
Vick Division
Research G. F.
Hoffnagle |
Combinations
approval Vicks Nyquil |
040297 |
Vick Division
Research G. F.
Hoffmangle |
Antitussive
with Antihistamine Vicks Formula
44 Cough Mixture |
040298 |
OTC Volume for
References |
Unpublished
data, Memos and Letters |
040299A 040299B |
Parke-Davis |
Presentation
on Benylin |
040300 |
Bristol-Myers |
Concerning
Combo. Policy |
040301 |
Wyeth
Labs./AMHO |
Concomitance
of Symptoms: Rhinorrhea & Cough |
040302 |
Hoffman-LaRoche |
Activity of
Commercial Anthistamines by an In Vivo Evaluation Method |
040303 |
Proprietary
Association |
Antihistamine
Animal Tests |
040304 |
Health
Research Group |
Combo. Policy |
040305 |
Pennwalt Corp. |
Presentation
regarding Timed Release Dosage Forms |
040306 to 040315 |
Vick/Richardson
Merrell |
Supplement to
Doxylamine succinate/Nov. 1974 |
040316 |
Hoffman-LaRoche |
Phenindamine
(thephorin) |
040317 |
Schiffman |
Asthmador |
040318 |
AMHO/Wyeth |
Promethazine
for allergy and in combo with Antitussive |
040319 |
Wyeth Labs. |
Promethazine
adverse Reactions |
040320 |
Parke-Davis |
Benadryl/Antitussive |
040321 |
Parke-Davis |
Benadryl/Antitussive
Appendix A |
040322 |
Vick Division
Research |
Supplement to
Vick Inhaler |
040323A 040323B |
FDA FDA |
Desi Reports Desi Reports |
040324 |
Wyeth Labs. |
Effectiveness
of Promethazine |
040325 |
FDA |
Epidemiology
Antihistamine Toxline Search |
040326 |
Parke-Davis L. M. Lueck |
Benylin Cough
Syrup (Benylin
Expectorant) |
040327 |
UpJohn Co. |
Bronchodilators
in Cough/Nadel |
040328 |
A. H. Robins |
Brompheniramine
maleate |
040329 |
Vick Division
Research |
Antitussive,
Analgesic-Antipyretic and Decongestant |
040330 |
Vick Division
Research |
Supplement to
Vicks Nyquil submission |
040331 |
Wyeth Labs. Daniel L. Shaw |
Promethazine
hydrochloride (Phenergan) |
040332 |
Smith Kline
& French Cheston
Simmons |
Summary of
data to support the drying action of antihistamines when prescribed for acute
coryza (common cold) for relieve of CCABA Panel |
040333 |
Warner-Lambert
Co. Richard C.
Brogle |
Thonzylamine
(Neohetramine) and Phenyltoloxamine |
040334 |
Warner-Lambert
Co. Richard C.
Brogle |
Warner Lambert
Co. Products |
040335 |
Vick Division
Research |
Comments
concerning dosage of specified dosage forms |
040336 |
Vick Division
Research |
Self-medication |
040337 |
Ciba-Geigy Edward C.
McKeon |
Nasal
decongestants Naphazoline
& Xylometazoline |
040338 |
NCI Study on
Chloroform |
Report on
Carcinogenicity |
040339 |
Fisons Corp. |
Antitussives
(noscapine) |
040340 |
Parke-Davis |
Diphenhydramine |
040341 |
Parke-Davis |
Diphenhydramine |
040342 |
Vick Chemical |
Statement on
DTC Cough/Colds principles applicable to combo. drugs |
TFM VOLUME:
04BTFM
Has been
established for Bronchodilator
Drug
Products
TFM VOLUME:
04CTFM
has been established for Anticholinergia
Drug
Products
TFM VOLUME:
04HTFM
Has been
established for Antihistamine
Drug
Products
TFM VOLUME:
04NTFM
Has been
established for Nasal
Decongestant
Drug Products
OTC
SEDATIVES, TRANQUILIZERS AND
SLEEP AIDS REVIEW PANEL
INDEX TO DATA SUBMISSIONS
VOLUME
NUMBER |
SUBMITTED
BY |
TRADE
NAME |
INGREDIENTS |
REMARKS |
050001 |
Monsanto Co. |
None |
Methapyrilene HCl Methapyrilene Fumarate |
Bulk Chemical Bulk Chemical |
050002 |
FDA ( |
None |
Miscellaneous Documents from FDA files -
Originally Submitted to DESI Study |
|
050003 (Box A) |
J. B. Williams Co. |
Sominex Tablets |
Scopolamine Aminoxide HBr. Methapyrilene HCl Salicylamide |
Submitted loose in boxes at Firms request |
050004 (Box B) |
|
Sominex Tablets |
Scopolamine Aminoxide Hbr Methapyrilene Hcl Salicylamide |
|
050005 |
|
Quiet World |
Acetaminophen Aspirin Methapyrilene Hcl Scopolamine Hbr. |
|
050006 |
|
Sleep-eze |
Methapyrilene HCl Scopolamine HBr |
|
050007 |
Block Drug Co. |
Nytol Tablets Nytol Capsules |
Methapyrilene HCl Scopolamine HBr Methapyrilene HCl Salicylamide |
|
050008 050009 |
Jeffrey Martin Inc. |
Compoz Tablets |
Pyrilamine maleate Methapyrilene HCl Scopolamine aminoxide HBr. |
|
050010 |
FDA (Dr. Chernov) |
|
|
Selected articles and papers |
050011 |
FDA (Medical Library) |
|
|
FDA Library Search Abstracts |
050012 |
FDA (OTC Staff) |
|
|
A Study of Health Practices and Opinions Final
Report FDA Contract No. 66-193, June, 1972 |
050013 |
FDA (OTC Staff) |
|
Methapyrilene HCL |
Drug Efficacy Study (NAS?NRC) Reports only one
drug was covered, DORMIN |
050014 |
Miles Labs. |
Miles Nervine |
Sodium bromide Potassium bromide Ammonium bromide |
|
050016 |
FDA (Dr. Chernov) |
|
Scopolamine |
Paper titled “Proprietary Hallucinogens” by
Leff and Bernstein |
050017 |
FDA (Medical Library) |
|
Salicylamide |
Limited literature search and bibliography on
Salicylamide with selected articles |
050018 |
Dr. Hartmann |
|
|
Selected Papers by Dr. Hartmann submitted to
the other Panel members at his request |
050019 |
Jeffrey martin Inc. |
Compoz Tablets |
|
Amendment to previous submission (050008)
“Appropriate and Inappropriate Methodology in the evaluation of OTC Daytime
Sedatives |
050020 |
Jeffrey Martin Inc. |
Compoz Tablets |
|
(More legible copy of Submission No. 050009) |
050021 |
J. B. Williams Co. |
|
|
Data on sedative properties of DOXYLAMINE and
PHENYLTOLOXAMINE |
050022 |
Miles labs. |
None |
Diphenhydramine Hydrochloride |
Data on the use of this agent as a
sedative-sleep aid |
050023 050024 |
Bristol-Myers |
Excedrin P.M. |
Aspirin Salicylamide Acetaminophen Methapyrilene furmarate |
|
050025 |
FDA |
|
|
Adverse Reactions Data on Bromides,
Scopolamino Compoz and Sominex requested by Panel |
050026 |
Miles Labs. |
None |
Diphenhydramine Hydrochloride |
Additional data submitted at Panel’s request |
050027 |
Bristol-Myers |
|
|
Additional data on Methapyrilene/Excedrin P.M. |
050028 |
Parke Davis |
|
Bendryl Diphenhybromide |
|
050029 |
Dr. Norris |
|
|
Toxicity Data |
050030 |
FDA |
|
|
Labeling information request by Panel |
050031 |
Endo. Labs. |
Percogesic Dilone |
Acetaminophen Phenyltoloxamine acetate Caffeine |
|
050032 |
Bristol-Myers |
Excedrin P.M. |
|
Additional Data |
050033 |
Bristol-Myers |
Excedrin P.M. |
|
Additional Data |
050034 |
Bristol-Myers |
Excedrin P.M. |
|
Additional Submission (Excedrin P.M.) |
050035 |
Parke Davis |
|
Benadryl |
|
050036 |
Jeffrey Martin |
Compoz |
|
Comments on Daytime Sedatives |
050037 |
Parke Davis |
|
Diphenhydramine (Bendryl) |
Additional data |
050038 |
Endo Labs. |
|
|
Additional information on percogesic |
050039 |
Parke Davis |
|
|
Study plan for Diphenhydramine |
050040 |
J.B. Williams |
|
|
Additional comments on Dr. Rickels study of
Compoz |
050041 |
Division of American Home Products |
|
Diphenhydramine |
Additional data |
050042 |
Division of American Home Products |
|
Diphenhydramine |
Data requestred by Panel |
050043 |
Sedative Panel Working Papers |
|
|
|
050044 |
|
Placin Calmative Capsules |
Paminobenzoic Acid Salicylamide Passiflora (Passion Flower) P.E. Euphorbia P.E. |
|
050045 |
Johnson & Johnson Co. |
|
|
Safety data on talc |
050046 |
American Home Products Corp. |
|
|
Target population for Daytime Sadatives |
050047 |
Lemming-Pacquin |
|
|
Comments on Doxylamine Succinate |
050048 |
FDA |
|
|
Hypnotic Testing guidelines |
050049 |
|
|
|
Referenences - Nighttime Sleep-Aids, Daytime
Sedatives, Stimulants A-E |
050050 |
|
|
|
References - Nighttime Sleep-Aids, Daytime
Sedatives, Stimulants F -K |
050051 |
|
|
|
References - Nighttime Sleep-Aids, Daytime
Sedatives, Stimulants L-R |
050052 |
|
|
|
References - Nighttime Sleep-Aids, Daytime
Sedatives, Stimulants S-Z |
050053 |
|
|
Scopolamine |
References - (uncited) |
050054 |
|
|
Scopolamine |
References - (uncited) |
050055 |
|
|
Miscellaneous |
References - (uncited) |
PUBLIC
ADMINISTRATIVE FILE
Sunscreen
Volumes
VOLUME |
COMPANY |
|
060001 |
|
A-Fil Cream |
060002 |
“ |
Sundare Creamy
Lotion |
060003 |
“ |
Sundare Clear
Lotion |
060004 |
“ |
Sun Stick Lip
Protectant |
060005 |
Felton
Chemical Co. |
Suncreme
Concentrate WMO |
060010 |
Van Dyck &
Co., Inc. |
Escalol 507 |
060018 |
“ |
Escalol 508 |
060019 |
“ |
Escalol 106 |
060021 |
Givaudan
Corporation |
Giv-Tan F |
060037 |
Menley &
James Labs |
Sea and Skin
Golden Tan |
060044 |
|
Sun Swept
Cream |
060057 |
Westwood
Pharm., Inc. |
PreSun Lotion |
060064 060065 060066 060067 |
Plough, Inc. “ ” “ |
Coppertone,
etc. “ Sudden Tan QT Foam |
060069 |
Rowell Labs,
Inc. |
Doushield Two,
One |
060070 060072 |
Plough, Inc. “ |
Sunshielding
Lotion Sun Protective
Foam |
060076 |
Lanvin -
Charles of the Ritz |
Ravenescence,
etc. |
060081 |
Westwood Pham. |
Presun,
additional |
060083 |
greiter Corp.
Int. |
Piz Buin, etc. |
060084 |
Amerchol |
Amerscreen P |
060086 |
E. M. Labs |
Eusolex, etc. |
060088 |
Felton Chem.
Co. |
Sunarome Conc. |
060089 |
Haarman &
Reimer Corp. |
Neo Heliopan
AV |
060090 |
E. M. Labs |
Eusolex -
additional data |
060091 |
Bonne Bell
Inc. |
Triethanolamine
salicylate |
060093 |
E. M. Labs |
Eusolex 3573 -
additional data |
060103 060104 |
G. S. Herbert
Labs “ |
Eclipse |
060105 |
Amerchol |
Amerscreen P |
060110 |
Givaudan Corp. |
Parsol MX,
Parsol Hydro |
060115 |
E. M. Labs |
Eusolex 6300 |
060116 |
Miles Labs |
Sunguard |
060117 |
Chattem Labs |
Alpaba |
060120 |
Elizabeth
Arden Inc. |
Sun Gelee |
060125 |
Texas
Pharmacal Co. |
A-Fil -
additional data |
060128 |
GAF Corp. |
Technical
information |
060129 |
Hill Top
Research |
Sunscreens |
060130 |
Greiter Corp. |
Additional
data |
060131 |
Plough, Inc. |
Additional
data |
060134 |
Scher Chemical
|
Dipsal |
060135 |
Plough, Inc. |
Sun Protective
Lotion |
060143 |
Greiter Corp. |
UV Filters |
060145 |
Van Dyck |
Additional
data |
060147 |
Schuylkill
Chem. Co. |
Alpaba -
additional data |
060148 |
Westwood
Pharm. |
Presun -
additional data |
060151 |
Felton Int. |
Sunarome |
060154 |
Paul B. Elder |
RVP with
Magnasurf |
060155 |
PA/CTFA
comment on sunscreens |
|
060157 |
Greiter |
Additional
data |
060158 |
Hill Top |
Comments |
060159 |
Johnson &
Johnson |
Testing |
060162 |
Givaudan |
Parsol MCX |
060163 |
Elizabeth
Arden |
Suncare Line |
060164 |
Plough, Inc. |
Testing |
060165 |
AVA, Inc. |
Aloe Vera Gel
for Sun, Vehicles |
060166 060167 |
Westwood “ |
Label comments Protocol for
tests |
060168 |
Johnson &
Johnson |
|
060169 |
CTFA/PA |
Comparative
tests |
060170 |
Plough |
Skin cancer
data |
060171 |
Ingram Pharm.
Co. |
UV absorber 3 |
060175 060176 060177 |
Westwood Johnson &
Johnson Dome Labs |
Comments on
sunscreen draft “ ” |
060182 |
References,
Cited |
|
060183 |
References,
Uncited |
|
060185 |
References,
Cited--Measurements of UV
Radiation in the |
|
Panel
Administrator’s File (Correspondence File), Volume I
Panel
Administrator’s File (Correspondence File), Volume II
Minutes of the
OTC Panel on Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn
Treatment and Prevention Drug Products
Skin Protectants
VOLUME |
COMPANY |
SUBJECT |
060007-A |
E. R. Squibb |
Zinc Oxide
Ointment |
060011 |
Gebauer Chem.
Co. |
Gebauer’s
Tannic Spray |
060034 |
Church &
Dwight Co., Inc. |
Sodium
bicarbonate |
060065 (see
sunscreen vols) |
Plough, Inc. |
Coppertone Lip
Balm |
060080-B |
Calhoun’s Lab. |
Burn-O-Jel |
060109 |
Chesebrough-Pond’s
Inc. |
Vaseline |
060112 |
|
Sperti Healing
Ointment |
060113 |
|
Digene Chafing
Ointment |
060114 |
|
Digene
Chafling Ointment |
060123-A |
Bowman Pharm.,
Inc. |
Almophen
Ointment Calamine
Compound Easte Caloxol Lotion Petrozine
Ointment |
060137 |
Plough, Inc. |
Mexsana
Medicated Powder |
060149 |
American Home
Products Co. |
Additional SRF
data |
060152 |
Otis Clapp
& Sons |
Obtundia
Calamine Cream |
060160 |
American Home
Products Co. |
Additional SRF
data |
060172 |
Plough, Inc. |
Dimethicone |
ADMINISTRATIVE FILE
Skin Protectant Drug Products for OTC Human Use
Establishment of a Monograph and Reopening of
Administrative
Record
Docket No.
78N-0021
Volume
06DPA2
In the FEDERAL REGISTER of September 7, 1982 (47
FR 39436), the administrative record for the OTC skin protectant drug products
rulemaking was reopened to include 5 statements by the Advisory Review Panel on
OTC Miscellaneous External Drug Products.
To avoid duplication, the Public administrative file
for the OTC external Analgesic Drug Products rulemaking (Docket No. 78N-0301)
that was also reopened on September 7, 1982 (47 FR 39412).
The name of each statement included in the skin
protectant rulemaking and its corresponding volume number in the external
analgesic administrative file appears below.
Statement Volume
No.
OTC Drug Products for the Treatment of 06BPA6
Diaper Rash
OTC Drug Products for the Prevention of 06BPA7
Poison Ivy, Oak, and Sumac
OTC Drug Products for the Treatment of 06BPA8
Fever Blisters
OTC Astringent Drug Products 06BPA10
OTC Insect Bite Neutralizer Drug Products 06BPA11
PUBLIC
ADMINISTRATIVE FILE
OTC EXTERNAL
ANALGESIC DRUG PRODUCTS
Docket
No. 78N-0301
VOLUME |
SUBMITTED BY |
|
060005* |
Monsanto
Industrial Chem. Co. |
Methyl
salicylate |
060007-B |
E.R. Squibb
& Sons, Inc. |
Counterpain
Rub |
060008 |
Wm. P.
Poythress |
Panalgesic |
060009 |
Yager Drug Co. |
Yager’s
Liniment |
060011 |
Gebauer
Chemical Co. |
Gebauer’s
Tannic Spray |
060012 |
Ciba-Geigy,
Inc. |
Nupercainal
Cream, etc. |
060013 |
Ciba-Geigy,
Inc. |
Nupercainal
Cream, etc. |
060014 |
Brown Medicine
Co. |
Brown’s N
& B Liniment |
060015 |
Carbisulphoil
Co. |
Foille Liquid
& Ointment |
060016 |
Carbisulphoil
Co. |
Foille Liquid
& Ointment |
060017 |
C. G. Smith
Products Co. |
Gypsy Rub
Liniment |
060017 |
Geriatric
Pharm Co. |
Ger-O-Foam |
060017 |
Wade Chemical
Corp. |
Jim Wade Deep
Treet Liniment |
060017 |
Berry &
Withington Co. |
Analgesic Balm |
060017 |
Meyer Brothers
Drug Co. |
Bet-U-Lol |
060020 |
Astra Pharm.
Products Inc. |
Xylocaine
Ointment |
060022 |
The
Mentholatum Co. |
Mentholatum
Deep Heating Lotion |
060023 |
The
Mentholatum Co. |
Mentholatum
Deep Heating Rub |
060024 |
Warren-Teed
Pharm., Inc. |
Myoflex Cream |
060025 |
The Dow
Chemical Co. |
Creme Dyclone |
060026 |
Smith, Kline
& French Labs |
Quotane
Lotion, etc. |
* Sequential
volume numbers not on this list are already on file with the Hearing Clerk, as
follows:
OTC
Topical Otic Drug Products, Docket No. 77N-0334,
OTC
Skin Protectant Drug Products, Docket No. 78N-0021,
OTC
Sunscreen Drug Products, Docket No. 78N-0038
VOLUME |
SUBMITTED BY |
SUBJECT |
060027 |
Whitehall
Labs, Inc. |
Outgro |
060029 |
Whitehall
Labs, Inc. |
Instant Heet Spray |
060030 |
Whitehall
Labs, Inc. |
Heet Analgesic
Liniment |
060031 |
Whitehall
Labs, Inc. |
Heet Gel |
060032 |
Whitehall
Labs, Inc. |
Anbesol |
060033 |
Whitehall
Labs, Inc. |
Infrarub |
060035 |
W. F. Young,
Inc. |
Asborbine, Jr. |
060036 |
W. F. Young,
Inc. |
Absorbine
Arthritic Pain Lotion |
060038 |
Resinol
Chemical Co. |
Resinol
Ointment, Cream |
060039 |
Abbott Labs |
Butesin
Picrate Ointment |
060040 |
Warner-Lambert
Research Institute |
Sloan’s
Liniment, Balm |
060041 |
Norwich
Pharmacal Co. |
Unquentine
Aerosol |
060042 |
Norwich
Pharmacal Co. |
Unquentine
Ointment |
060043 |
Norwich
Pharmacal Co. |
Unquentine
Plus |
060045 |
Abbott Labs |
Tronothane HCl |
060046 |
Pfizer, Inc. |
Un-Burn |
060047 |
Sterling Drug,
Inc. |
Pontocaine
Cream |
060048 |
Sterling Drug,
Inc. |
Pontocaine
Ointment |
060049 |
Sterling Drug,
Inc. |
Medi-Quick |
060050 |
Denver
Chemical Mfg. Co. |
Dencorub |
060051 |
Plough, Inc. |
Musterole |
060052 |
Denver
Chemical Mfg. Co. |
Antiphlogistine |
060053 |
Sterling Drug,
Inc. |
Campho-Phenique |
060054 |
Denver
Chemical Mfg. Co. |
Pain Away |
060055 |
Plough, Inc. |
Solarcaine
Cream, etc. |
060056 |
Pfizer, Inc. |
Ben-Gay
Ointment - Lotion |
060058 |
Combe, Inc. |
Lanacane Spray |
060059 |
Combe, Inc. |
Soak’n Massage |
060060 |
Combe, Inc. |
Lanacane Cream |
060061 |
Medical Supply
Co. |
MSCo Burn
Compound, etc. |
060062 |
Quist Chemical
Co. |
A’MAY’S-On
Ointment |
060063 |
Enegoltaria
Medicine Co. |
Linimento
Daire, etc. |
060068 |
Ciba
Pharmaceutical Co. |
Pyribenzamine
Cream, etc. |
060071 |
Plough, Inc. |
Dermasol
Cream, Foam, Lotion |
060073 |
Arnar-Stone
Labs, Inc. |
Americaine Sun
Balm, etc. |
060074 |
The R.
Schattner Co. |
Oraderm, etc |
060075 |
Sperti Drug
Products |
Aspercreme |
060077 |
Block Drug
Co., Inc. |
Omega Oil |
060080-B |
Calhoun’s
Laboratory |
Burn-O-Jel |
060082 |
M. S. Glorius
Co. |
Glourius Pain
Relief |
060085 |
Noxell Corp. |
Noxzema Skin
Cream |
060087 |
W. F. Young,
Inc. |
Absorbine
Jr.-additional data |
060092 |
Whitehall
Labs, Inc. |
Infrarub-additional
data |
060094 |
Carbisulphil
Co. |
8-hydroxyquinoline |
060095 |
Parke, Davis
& Co. |
Benadryl, etc. |
060096 |
Noxell Corp. |
Noxzema-additional
data |
060097 |
Plough, Inc. |
Hydrocortisone
preparations |
060098 |
Plough, Inc. |
Hydrocortisone
preparations |
060099 |
Plough, Inc. |
Hydrocortisone
preparations |
060100 |
Plough, Inc. |
Hydrocortisone
preparations |
060101 |
Plough, Inc. |
Hydrocortisone
preparations |
060102 |
Plough, Inc. |
Hydrocortisone
preparations |
060106 |
Ciba-Geigy, Inc. |
Vioform-Hydrocortisone |
060107 |
Ciba-Geigy,
Inc. |
Vioform-Hydrocortisone |
060108 |
Ciba-Geigy,
Inc. |
Vioform-Hydrocortisone |
060111 |
Plough, Inc. |
Musterole,
etc. |
060118 |
C. F. Kirk
Labs |
Exocaine-additional
data |
060119 |
Rexall Drug
Co. |
Thru, Intracel |
060121 |
C. F. Kirk
Labs |
Exocaine-additional
data |
060122 |
Dermik Labs |
Hydrocoortisone
comments |
060123-B |
Bowman Pharm.,
Inc. |
Liquid
Analgesic, etc. |
060124 |
|
Report on
Hydrocortisone |
060126 |
C. F. Kirk
Labs |
Exocaine-additional
data |
060127 |
Pfizer, Inc. |
Ben-Gay-additional
data |
060132 |
C. F. Kirk
Labs |
Additional
data |
060133 |
Reed &
Carnrick Pharmaceuticals |
Tarcortin |
060136 |
C. F. Kirk
Labs |
Additional
data |
060138 |
Beecham
Products (formerly Calgon) |
S.T. 37 |
060139 |
Beecham
Products (formerly Calgon) |
S.T. 37 |
060140 |
Beecham
Products (formerly Calgon) |
S.T. 37 |
060141 |
Eli Lilly
& |
Surfadil |
060142 |
Eli Lilly
& |
Surfacaine |
060144 |
Warren-Teed
Pharm., Inc. |
Myoflex-additional
data |
060146 |
Sterling Drug,
Inc. |
Additional
data |
060150 |
Miscellaneous
submissions to the Panel |
|
060152 |
Otic Clapp
& Sons |
Obtundia, etc. |
060153 |
Carol Angle,
M.D. |
Comment on
camphor |
060156 |
B. F. Ascher
& Co. |
Mobisyl Creme |
060161 |
The Upjohn Co. |
Hydrocortisone
literature |
060173 |
W. F. Young,
Inc. |
Absorbine
Jr.-Supplement |
060174 |
W. F. Young,
Inc. |
Absorbine
Jr.-Supplement |
060178 |
FDA |
Hydrocortisone
data search-viral infections |
060179 |
Arnar-Stone
Labs, Inc. |
Presentation
to Panel on methemoglobinemia and benzocaine |
060180 |
American Home
Products |
Statement to
the Panel |
060186 |
|
References
cited in report A-C |
060187 |
|
References
cited in report D |
060188 |
|
References
cited in report E-G |
060189 |
|
References
cited in report H-L |
060190 |
|
References
cited in report M-P |
060191 |
|
References
cited in report Q-S |
060192 |
|
References cited
in report T-Z |
060193 |
|
References
evaluated but not cited in report A-B |
060194 |
|
References
evaluated but not cited in report C-D |
060195 |
|
References
evaluated but not cited in report E-G |
060196 |
|
References
evaluated but not cited in report H-L |
060197 |
|
References
evaluated but not cited in report M-R |
060198 |
|
References
evaluated but not cited in report S-Z |
060199 |
|
Abstracts of
Bibliography - Topical Analgesic ingredients |
060202 |
Miles
Laboratories, Inc. |
Cort-Dome
Hydrocortisone |
060203 |
Miles Laboratories,
Inc. |
Cort-Dome
Hydrocortisone |
060204 |
Miles
Laboratories, Inc. |
Cort-Dome
Hydrocortisone |
06BPA1 |
Panel
Administrator’s File, Volume I - General |
|
06BPA2 |
Panel
Administrator’s File, Volume II - Meeting Summary Minutes |
|
06BPA3 |
Panel
Administrator’s File, Volume III - Correspondence File (1972, 1973) |
|
06BPA4 |
Panel
Administrator’s File, Volume IV - Correspondence File (1974, 1975) |
|
06BPA5 |
Panel
Administrator’s File, Volume V - Correspondence File ( 1976, 1980) |
|
ADMINISTRATIVE FILE
External
Analgesic Drug Products
For
OTC Human Use; Establishment of a
Monograph
and Reopening of Administrative Record
Published
in the FEDERAL REGISTER on
September
7, 1982 (47 FR 39412)
Part
I
Statement on OTC Drug Products
For
the Treatment of Diaper Rash
Docket
No. 78N-0301
VOLUME |
|
06BPA6 |
1.1 Call for Data |
|
1.2 List of Panel Members and Liaisons |
|
1.3 Curriculum Vitae of Panel Memebers
and Liaisons |
|
1.4 General Charge to Panel |
|
1.5 Index to Panel Submissions |
|
1.6 Minutes of Panel Meetings |
|
1.7 Correspondence |
|
1.8 Cited References |
|
1.9 Uncited References |
External Analgesic Drug Products
for OTC Human Use; Establishment of a
Monograph
and Reopening of Administrative Record;
OTC Drug
Products for the Prevention of Poison Ivy,
Oak, and Sumac
Part
II
Docket
No. 78N-0301
Index
to OTC Volumes
VOLUME NO. |
SUBMITTED BY |
|
160074 |
Marion Health
and Safety, Inc. |
|
160103 |
Unimed, Inc. |
Residerm
(Poison Ivy Lotion) |
160132 |
Marion Health
and Safety, Inc. |
Zircreme,
Ferric Chloride, Sting-Kill |
160152 |
Marion Health
and Safety, Inc. |
|
ADMINISTRATIVE FILE
External
Analgesic Drug Products
for
OTC Human Use; Establishment of a
Monograph and Reopening
of Administrative Record
Published in
the FEDERAL REGISTER on
September 7, 1982 (47 FR 39412)
Part
II
Statement on
OTC Drug Products for the
Prevention
of Poison Ivy, Oak, and Sumac
Docket
No. 78N-0301
VOLUME |
CONTENTS |
06BPA7 |
1.1 Call for Data |
|
1.2 List of Panel Members and Liaisons |
|
1.3 Curriculum Vitae of Panel Members
and Liaisons |
|
1.4 General Charge to Panel |
|
1.5 Index to Panel Submissions |
|
1.6 Minutes of Panel Meetings |
|
1.7 Correspondence |
|
1.8. References |
External Analgesic Drug Products
for OTC Human
Use; Establishment of a
Monograph
and Reopening of Administrative Record;
OTC Drug Products for the Treatment of Fever
Blisters
Part
III
Docket
No. 78N-0301
Index to OTC Volumes
VOLUME NO. |
SUBMITTED BY |
|
160008 |
Commerce Drug
Co., Inc. |
Bio-Stik |
160012 |
Commerce Drug
Co., Inc. |
Tanac |
160013 |
Commerce Drug
Co., Inc. |
Tanac Stik |
160048 |
Campbell
Laboratories, Inc. |
Herpecin-L |
160096 |
Blistex, Inc. |
Blistex
Ointment |
160136 |
Sterling Drug
Inc. |
Campo-Phenique |
160177 |
International
Pharmaceutical Corp. |
Gly-Oxide Liquid |
160197 |
Oral
Prophylactic Assoc., Inc. |
Mouth Komfort |
160213 |
Blistex, Inc. |
Blistik Lip
Balm |
160218 |
Glenbrook
Laboratories |
Campho-Phenique |
160231 |
Sterling Drug,
Inc. |
Campho-Phenique |
ADMINISTRATIVE FILE
External
Analgesic Drug Products
For OTC Human Use; Establishement of a
Monograph
and Reopening of Administrative Record
Published
in the FEDERAL REGISTER on
September 7, 1982 (47 FR 39412)
Part
III
Statement on OTC Drug Products
For the Treatment of Fever Blisters
Docket
No. 78N-0301
VOLUME |
|
06BPA8 |
1.1 Call for Data |
|
1.2 List of Panel Members and Liaisons |
|
1.3 Curriculum Vitae of Panel Members
and Liaisons |
|
1.4 General Charge to Panel |
|
1.5 Index to Panel Submissions |
|
1.6 Minutes of Panel Meetings |
|
1.7 Correspondence |
|
1.8 References |
External Analgesic Drug Products
for OTC Human
Use; Establishment of a
Monograph
and Reopening of Administrative Record;
OTC Male Genital Desensitizing Drug
Products
Part
IV
Docket
No. 78N-0301
Index to OTC Volumes
VOLUME |
SUBMITTED BY |
|
160001 |
Frederick
Damrau, M.D. |
Culminal |
160014 |
Commerce Drug
Co., Inc. |
Detane |
160171 |
Ciba-Geigy
Corp. |
Nupercainal
Ointment |
160260 |
Keller and
Heckman for Pound International Corp. |
Stud-100 |
160266 |
Keller and
Heckman for Pound International Corp. |
Stud-100 |
160281 |
|
Detane |
160290 |
Commerce Drug
Co., Inc. |
Detane |
160388 |
|
Detane |
06BPA9-A |
|
Cited
References |
06BPA9-B |
|
Uncited
References |
ADMINISTRATIVE FILE
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph
and Reopening of Administrative Record
Published in the FEDERAL REGISTER on
September 7, 1982 (47 FR 39412)
Part
IV
Statement on
OTC Male Genital Desensitizing Drug Products
Docket
No. 78N-0301
Panel
Administrator’s File
VOLUME |
|
06BPA9 |
1.1 Call for Data |
|
1.2 List of Panel Members and Liaisons |
|
1.3 Curriculum Vitae of Panel Members
and Liaisons |
|
1.4 General Charge to Panel |
|
1.5 Index to Panel submissions |
|
1.6 Minutes of Panel Meetings |
|
1.7 Correspondence |
External Analgesic Drug Products
for OTC Human
Use; Establishment of a
Monograph and Reopening
of Administrative Record;
OTC Astringent Drug Products
Part
V
Docket
No. 78N-0301
Index
to OTC Volumes
VOLUMES NO. |
SUBMITTED BY |
|
160022 |
Marion
Laboratories Inc. |
Bluboro Powder |
160038 |
Dome
Laboratories |
Acid Mantle,
Creme, Lotion |
160039 |
Dome
Laboratories |
Domeboro
Tablets, Powder |
160069 |
Cooper
Laboratories, Inc. |
Acnaveen Bar,
Cream, Aveeno Bar, Bath, Oilated Bath, Avenol Bath Additive, Bur-Veen Wet
Dressing Powder, Emulave Bar, Nixoderm Ointment, Packers Pine Tar Shampoo,
Soap, Sebaveen Shampoo |
160070 |
Cooper
Laboratories, Inc. |
Acnaveen Bar,
Cream, Aveeno Bar, Bath, Oilated Bath, Avenol Bath Additive, Bur Veen Wet
Dressing Powder, Emulave Bar, Nixoderm Ointment, Packers Pine Tar Shampoo,
Soap, Sebaveen Shampoo |
160093 |
R. L. Gaddy |
Ez-It Medicted
Foot Powder |
160140 |
Marion
Laboratories, Inc. |
Bluboro Powder |
160219 |
Marion
Laboratories, Inc. |
Bluboro Powder |
160230 |
Marion
Laboratories, Inc. |
Bluboro Powder |
160233 |
Cox Drugs |
Formula “U” |
160354 |
Humpheys
Pharmacal, Inc. |
Witch Hazel |
160396 |
Stiefel
Research Institute, Inc. |
AluWets |
160409 |
Perito, Duerk,
Carlson & Pinco for Requa Manufacturing Co., Inc. |
Aluminum
Sulfate Styptic Pencil |
160413 |
The Woltra
Company, Inc. |
Aluminum
Sulfate Styptic Pencil |
160428 |
The E. E.
Dickinson Co. |
Witch Hazel |
160429 |
Beecham
Products |
OTC Astringent
Vaginal Douche Drug Products |
160433 |
American
Distilling and Manufacturing Co., inc. |
Witch Hazel
Study |
160435 |
Requa
Manufacturing Co., Inc. |
Aluminum
Sulfate |
06BPA10-A |
|
Cited
References |
06BPA10-B |
|
Uncited
References |
ADMINISTRATIVE FILE
External
Analgesic Drug Products
for OTC Human
Use; Establishment of a
Monograph
and Reopening of Administrative Record
Published
in the FEDERAL REGISTER on
September
7, 1982 (47 FR 39412)
Part
V
Statement on OTC
Astringent Drug Products
Docket No.
78N-0301
Panel
Administrator’s File
VOLUME |
|
06BPA10 |
1.1 Call for Data |
|
1.2 List of Panel Members and Liaisons |
|
1.3 Curriculum Vitae of panel Members
and Liaisons |
|
1.4 General Charge to Panel |
|
1.5 Index to Panel Submissions |
|
1.6 Minutes of Panel Meetings |
|
1.7 Correspondence |
External Analgesic Drug Products
for OTC Human
Use; Establishment of a
Monograph
and Reopening of Administrative Record;
OTC Insect Bite Neutralizer Drug
Products
Part
VI
Docket
No. 78N-0301
Index
to OTC Volumes
VOLUME NO. |
SUBMITTED BY |
|
160074 |
Marion Health
and Safety, Inc. |
Sting Kill
Swabs |
160119 |
Tender Corp. |
After Bite |
160132 |
Marion Health
and Safety, Inc. |
Sting Kill
Swabs |
160159 |
Marion Health
and Safety, Inc. |
Sting Kill
Swabs |
160434 |
Tender Corp. |
After Bite |
ADMINISTRATIVE FILE
External Analgesic Drug Products
for OTC Human Use;
Establishment of a
Monograph
and Reopening of Administrative Record
Published
in the FEDERAL REGISTER on
September 7, 1982 (47FR 39412)
Part
VI
Statement on
OTC Insect Bite Neutralizer Drug Products
Docket
No. 78N-0301
VOLUME |
|
06BPA11 |
1.1 Call for Data |
|
1.2 List of Panel Members and Liaisons |
|
1.3 Curriculum Vitae of Panel Members
and Liaisons |
|
1.4 General Charge to Panel |
|
1.5 Index to Panel Submissions |
|
1.6 Minutes of Panel Submissions |
|
1.7 Correspondence |
|
1.8 References |
ADMINISTRATIVE FILE
Skin
Protectant Drug Products for OTC Human Use
Establishment
of a Monograph and Reopening of Administrative Record
Docket
No. 78N-0021
Volume
06DPA2
In the FEDERAL REGISTER of September 7, 1982 (47
FR 39436), the administrative record for the OTC skin protectant drug products
rulemaking was opened to include 5 statements by the Advisory Review Panel on
OTC Miscellaneous External Drug Products.
To avoid duplication, the Public Administrative File for these 5
statements appears as parts of the administrative file for the OTC external
analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened
on September 7, 1982 (47 FR 39412).
The name of each statement included in the skin
protectant rulemaking and its corresponding volume number in the external
analgesic administrative file appears below.
STATEMENT |
|
OTC Drug
Products for the Treatment of Diaper Rash |
06BPA6 |
OTC Drug
Products for the Prevention of Poison Ivy, Oak, and Sumac |
06BPA7 |
OTC Drug
Products for the Treatment of Fever Blisters |
06BPA8 |
OTC Astringent
Drug Products |
06BPA10 |
OTC Insect
Bite Neutralizer Drug Products |
06BPA11 |
TFM VOLUME 060TFM
Has been established for Topical Otic
Drug Products
TFM VOLUME 06BTFM
Has been established for EXTERNAL
ANALGESIC
DRUG PRODUCTS PART OF TOPICAL
ANALGESIC
TFM VOLUME 06DTFM
Has been established for Skin Protectant
Drug Products
Docket No.
80N-0476
PUBLIC
ADMINISTRATIVE FILE
TOPICAL
ANTIFUNGAL VOLUMES
VOLUME |
COMPANY |
PRODUCT OR SUBJECT |
070001 |
Wade Chemical
Corp. |
Jim Wade Foot
Powder |
070004 |
Laboratory
Robaina, Inc. |
Acetolia
Robaina |
070008 |
Givaudan Corp. |
G-4
(Dichlorophen) |
070010 |
Schering Corp. |
Tinactin
Cream, Tinactin Powder, Tinactin Powder Aerosol, Tinactin Solution, Tinactin
Solution Aerosol |
070017 |
Norwich
Pharmacal Co. |
NP-27 Cream |
070018 |
Norwich
Pharmacal Co. |
NP-27 Liquid |
070019 |
Norwich
Pharmacal Co. |
NP-27 Aerosol |
070020 |
Norwich
Pharmacal Co. |
NP-27 Powder |
070022 |
Pennwalt Corp. |
Cruex
Medicated Spray-On Powder |
070024-25 |
Pennwalt Corp. |
Desenex
Ointment, Desenex Powder, Desenex Solution, Desenex Spray-On Powder |
070029 |
Pennwalt Corp.
|
Cruex
Medicated Spray-On Powder |
070032 |
Wyeth
Laboratories, Inc. |
Sopronol
Ointment, Sopronol Powder, Sopronol Solution |
070033 |
Dermik
Laboratories, Inc. |
Two articles
on coal tar |
070034 |
William H.
Rorer, Inc. |
Carfusin |
070042 |
W.F. Young,
Inc. |
Absorbine
Athlete’s Foot Powder |
070043 |
W.F. Young,
Inc. |
Absorbine Jr. |
070045 |
La Wall &
Harrisson, Inc. |
Ecco Medicated
Powder |
070057 |
Upjohn Co. |
Medicated Foot
Powder |
070058 |
Upjohn Co. |
Fluid
Salicresin |
070065 |
R.L. Gaddy |
Ez-It |
070066 |
Red Foot
Products |
Red Foot
Powder |
070068 |
Ciba-Geigy
Corp. |
Vioform Cream,
Vioform Ointment, Vioform Powder |
070085 |
Texas
Pharmacal Co. |
Verdefam
Cream, Verdefam Solution |
070087 |
Ayerst
Laboratories |
Enzactin
Aerosol, Enzactin Cream, Enzactin Powder |
070095 |
|
Article on
borax and boric acid |
070100 |
Schuylkill
Chemical Co. |
Articles on
alcloxa, allantoins |
070101 |
R. Schattner
Co. |
Chloraderm |
070107 |
Magnesia
Products, Inc. |
Sporodyne |
070108 |
Smith, Kline
& French Laboratories |
Pragmatar |
070134 |
Chattem Drug
& Chemical Co. |
Blis-To-Sol Aerosol Powder, Blis-To-Sol
Liquid, Blis-To-Sol Medicated Gel, Blis-To-Sol Powder |
070135 |
Scholl, Inc. |
Solvex
Athlete’s Foot Powder |
070136 |
Scholl, Inc. |
Solvex
Athlete’s Foot Spray Powder |
070137 |
School, Inc. |
Solvex
Athlete’s Foot Spray |
070138 |
Scholl, Inc. |
Solvex
Athlete’s Foot Liquid |
070139 |
School, Inc. |
Solvex
Athlete’s Foot Ointment |
070140 |
Carbisulphoil
Co. |
Articles on
sulfur |
070141 |
Pennwalt Corp. |
Calcium
undecylenate/hydrocortisone acetate cream |
070146 |
Rystan Co.,
Inc. |
Prophyllin
Ointment, Prophyllin Powder |
070147 |
Plough, Inc. |
Aftate Gel,
Aftate Powder, Aftate Spray Liquid, Aftate Spray Powder |
070148 |
Cramer
Products, Inc. |
Fung-O-Spray |
070151 |
Cramer
Products, Inc. |
Cramer Foot
Ointment |
070152-4 |
Ciba-Geigy
Corp. |
Vioform-Hydrocortisone
Cream, Vioform-Hydrocortisone Liquid, Vioform-Hydrocortisone Mild Cream,
Vioform-Hydrocortisone Mild Ointment, Vioform-Hydrocortisone Ointment |
070157 |
Schering Corp. |
Tinactin
Powder, Tinactin Powder Aerosol |
070158 |
Pennwalt Corp. |
Desenex |
070160 |
Ciba-Geigy
Corp. |
Vioform-Hydrocortisone |
070161 |
Buckman
Laboratories, Inc. |
Buderma First
Aid Ointment |
070162 |
Gillette Co. |
Foot Guard
Foot Powder |
070163-4 |
Gillette Co. |
Foot Guard
Foot Deodorant Spray |
070165 |
Wyeth
Laboratories, Inc. |
Sopronol |
070169 |
Texas
Pharmacal Co. |
Verdefam |
070170-1 |
Norcliff
Thayer Inc. |
Tolindate |
070177 |
Schering Corp. |
Tinactin
Cream, Tinactin Powder, Tinactin Powder Aerosol, Tinactin Solution, Tinactin
Solution Aerosol |
070178 |
R. Schattner
Co. |
Studies on
phenol |
070179 |
Ciba-Geigy
Corp. |
Letter
regarding new data on Vioform, Vioform-Hydrocortisone |
070180 |
Givaudan Corp. |
Dichlorophen
safety study |
070182 |
Clairol
Research Laboratories |
Resorcinol
toxicity studies |
070183 |
Johnson &
Johnson |
Talc report |
070184 |
Warner-Lambert
Co. |
Review of
methyl salicylate safety and effectiveness |
070185 |
Johnson &
Johnson |
Article on
talc |
070186 |
Otis Clapp
& Son, Inc. |
Obtundia
Antiseptic Swab Pads, Obtundia First Aid Spray |
070189 |
Pennwalt Corp. |
Desenex |
070190 |
W.F. Young,
Inc. |
Absorbine
Athlete’s Foot |
070192 |
Otis Clapp
& Son, Inc. |
Obtundia
Surgical Dressing |
070193 |
Ciba-Geigy
Corp. |
Vioform,
Vioform-Hydrocortisone |
070194-5 |
Ferro Corp. |
Chloroxylenol
safety and effectiveness |
070196 |
W.F. Young,
Inc. |
Chloroxylenol
safety and effectiveness |
070197 |
Ferro Corp. |
Chloroxylenol |
070198 |
Pennwalt Corp. |
Prophylactic
efficacy of undecylenic acid |
070200 |
Pennwalt Corp. |
Chloroxylenol
irritation and sensitization studies |
070201-2 |
Reckitt &
Colman |
Chloroxylenol
safety and effectiveness |
070204 A&B |
Johnson &
Johnson |
Miconazole
nitrate cream |
070208 |
Pennwalt Corp. |
Chloroxylenol |
070209 |
Ciba-Geigy
Corp. |
Vioform,
Vioform-Hydrocortisone |
070210-1 |
W.F. Young,
Inc. |
Absorbine, Jr.
|
070212 |
Pennwalt Corp. |
Denenex |
070214 |
W.F. Young,
Inc. |
Absorbine, Jr.
statistical data |
070215 |
Johnson &
Johnson |
Miconazole
nitrate labeling claims |
070216 |
Schering Corp. |
Tolnaftate/nystatin
cream |
070217 |
Johnson &
Johnson |
Miconazole
nitrate/hydrocortisone cream |
070219 |
Westwood
Pharmaceuticals Inc. |
Halotex Cream,
Halotex Solution |
070220-1 |
|
Literature
review on toxicity of boric acid and sodium tetraborate |
070222 |
Proprietary
Association |
Labeling
claims |
070223 |
Johnson &
Johnson |
Labeling
claims |
070224 |
Proprietary
Association |
Paper on
guinea pig model |
070225 |
Pennwalt Corp. |
Paper on
fungicidal testing |
070226 |
W.F. Young,
Inc. |
In vivo guinea
pig studies |
070227 |
Ferro Corp. |
Chlorooxylenol
in vitro data |
070228 |
Richardson-Merrell,
Inc. |
Resorcinol
safety |
070229 |
Purdue
Frederick Co. |
Isodine
Athlete’s Foot Solution |
070231 |
Pennwalt Corp. |
Cruex
Medicated Cream |
070232 |
R. Schattner
Co. |
Letter
requesting reclassification of phenol |
070233 |
Ciba-Geigy
Corp. |
Vioform,
Vioform-Hydrocortisone in vitro data |
070237 |
Westwood Corp. |
Haloprogin
Anti-candidal data |
070240 |
Schering Corp. |
Summary of
tolnaftate safety |
070241 |
R. Schattner
Co. |
Letter on
phenol |
070243 |
Purdue
Frederick Co. |
Chemistry of
povidone-iodine |
070246 |
Rilox Co. |
|
070247 |
Sterling Drug,
Inc. |
Campho-Phenique
Liquid |
070249 |
Sterling Drug,
Inc. |
Campho-Phenique
Liquid, Campho-Phenique Powder |
070251 |
Stiefel
Laboratories, Inc. |
Salicylic Acid
and Sulfur Soap |
070252 |
Schering Corp. |
Tolnaftate |
070253 |
Sterol
Controls Co. |
Candicidin |
070254 |
Westwood
Pharmaceuticals, Inc. |
Halotex |
070257 |
Schering Corp. |
Tinactin |
070258 |
Purdue
Frederick Co. |
Povidone-iodine |
070265 |
Ciba-Geigy
Corp. |
Iodochlorhydroxyquin |
070266 |
Pennwalt Corp. |
Comments on
antifungal report |
070267 |
Wyeth
Laboratories |
Caprylate and
propionate combinations |
070301-307 |
Antifungal
References, Cited |
|
070308-310 |
Antifungal
References, Uncited |
|
07APA1 |
Panel
Administrator’s File |
Volume I -
General |
07APA2A&B |
Panel
Administrator’s File of panel meetings |
Volume II -
Minutes |
07APA3 |
Panel
Administrator’s File, Correspondence File (1978 - 1982) |
Volume IV - |
Docket No. 81N-0114
PUBLIC
ADMINISTRATIVE FILE
TOPICAL ACNE VOLUMES
VOLUME |
COMPANY |
|
070002 |
William P.
Poythress & Co. |
Bensulfoid
Lotion |
070004 |
Laboratory
Robaina, Inc. |
Acetolia
Robaina |
070005 |
E.R. Squibb
and Sons |
Epi*Clear
Antiseptic Lotion 10% Epi*Clear Antiseptic Lotion 5% Epi*Clear Acne
Lotion |
070006 |
Miranol
Chemical Co., Inc. |
Miranol C2M |
070009 |
|
Dermakon
Dandruff Shampoo |
070022 |
Pennwalt Corp. |
Ting
Antiseptic Medicated Cream |
070030 |
Campana Corp. |
Cuticura
(Cutitone) Acne Cream |
070036-7 |
Warner Lambert |
Listerex
Antibacterial Acne Scrub |
070038-41 |
Vick Divisions
Research |
Clearasil
Regular Tinted, Clearasil Stick Medication, Clearasil Vanishing Formula |
070046-47 |
|
Dermakon
Medicated Cream |
070048 |
USV
Pharmaceutical Corp. |
Oxy-5 |
070053 |
Upjohn Co. |
Plexion |
070056 |
Upjohn Co. |
Zinc Sulfide
Compound Lotio, Improved |
070060 |
Flow
Pharmaceuticals |
d-Seb |
070070 |
Texas
Pharmacal Co. |
Sulforcin
Lotion |
070071 |
Texas
Pharmacal Co. |
Sulforcin Base
4% |
070072 |
Texas
Pharmacal Co. |
Liquimat |
070073 |
sterling Drug,
Inc. |
pHisoAc |
070083 |
Sterling Drug,
Inc. |
Stri-dex
Medicated Pads |
070086 |
Texas
Pharmacal Co. |
Contrablem |
070088 |
Barnes-Hind
Pharmaceuticals |
Komed Acne
Lotion Komed Mild
Acne Lotion |
070089 |
Westwood
Pharmaceuticals |
Fostril |
070090 |
Westwood
Pharmaceuticals |
Pernox |
070092 |
Westwood
Pharmaceuticals |
Fostex Cake Fostex Cream |
070093 |
Westwood
Pharmaceuticals |
Transact |
070096 |
Helena
Rubinstein, Inc. |
Bio-Clear
Medicated Cream |
070097-99 |
Texas
Pharmacal Co. |
Persadox Cream Persadox
Lotion |
070100 |
Schuylkill
Chemical Co. |
Alcloxa,
Allantoin |
070101 |
R. Schattner
Co. |
Chloraderm |
070102-4 |
William H.
Rorer |
Loroxide
Lotion Vanoxide
Lotion |
070105 |
Syntex |
Microsyn Acne
Lotion |
070106 |
Fox Pharmacal,
Inc. |
Aktex |
070109 |
Smith, Kline,
& French |
Acnomel Acne
Cake Acnomel Acne
Cream |
070113 |
Stiefel labs |
Sulfoxyl Cream
Strong Sulfoxyl
Lotion Strong |
070124 |
Campana
Corporation |
Cuticura Acne
Cream (Cutitone) |
070126 |
E.R. Squibb
and Sons |
Epi*Clear Acne
Lotion, Epi*Clear Acne Scrub Cleanser, Epi*Clear Acne Soap, Epi*Clear Squibb
Acne Kit |
070155-56 |
Warner-Lambert |
Listerex Antibacterial
Scrub |
070168 |
Carter
Products |
Persol |
070172 |
Chattem Labs |
Mudd |
070173-5 |
Dome (division
of Miles) |
Acne-Dome
Medicated Cleanser Acne-Dome
Cream, Lotion |
070181 |
Sterling Drug,
Inc. |
Stri-dex
Medicated Pads |
070188 |
Warner-Lambert |
Listerex
Herbal Scrub |
070191 |
Pennwalt Corp. |
Bare Face Acne
Skin Medicine |
070199 |
Norcliff
Thayer |
Oxy-10, Oxy-5 |
070206 |
Barnes-Hind
Pharmaceuticals |
Komex Acne
Scrub |
070207 |
AHC Pharmacal |
bp Gel
Medication Strong, bp Gel Medication |
070218 |
Barnes-Hind
Pharmaceuticals |
Komex Acne
Scrub |
070230 |
H.B.
Distributing |
Hospital Brand
Acne Cream |
070234-6 |
Vick Divisions
Research |
Clearasil
Stick Clearasil
Regular Tinted Clearasil
Vanishing Cream |
070238 |
Norcliff
Thayer |
Oxy-5 Oxy-10 |
070239 |
Purdue
Frederick Co. |
Betadine Skin
Cleanser |
070242 |
Sterling Drug,
Inc. |
Stri-dex |
070243 |
Purdue
Frederick Co. |
Chemistry of
povidone-iodine |
070244 |
Bowman
Pharmaceuticals, Inc. |
Bowman Drawing
Paste |
070245 |
Press Chemical
& Pharmaceuticals labs, Inc. |
Wpsal Ointment |
070247 |
Sterling Drug,
Inc. |
Campho-Phenique
Liquid |
070248 |
dome (division of Miles Lab, Inc.) |
Vlem-Dome |
070249 |
Sterling Drug,
Inc. |
Campho-Phenique
Liquid |
070250 |
Dome |
Vlem-Dome |
070255 |
Procter &
Gamble |
Tetracycline |
070256 |
Avon Products,
Inc. |
Clear Skin
Medicated Blemish Cream |
070259 |
Stiefel Labs,
Inc. |
Sulfoxyl
Lotion |
070260 |
Sterling Drug,
Inc. |
Salicylic acid |
070261 |
Stiefel Labs,
Inc. |
SAStid Soap |
070262 |
The
Proprietary Assn. |
Benzoyl
peroxide safety |
070263 |
Herbert labs |
Benzoyl
peroxide |
070264 |
Vick Divisions
Research |
Benzoyl
peroxide |
070268 |
Westwood
Pharmaceuticals |
Pernox |
070269 |
Vick Divisions
Research |
Resorcinol |
070270 |
Herbert Labs |
Benzoyl
peroxide |
070271 |
Vick Divisions
Research |
Resorcinol |
070272 |
Vick Divisions
Research |
Clearasil |
020273 |
Westwood
Pharmaceuticals |
Laureth-4
(Polyoxyethylene-lauryl ether) |
070274 |
Westwood
Pharmaceuticals |
Polyethylene
Granules |
070275 |
Warner-Lambert
Co. |
Thymol and
polyethylene |
070276 |
Press Chemical
Co. |
Epsal Ointment |
070277 |
The
Proprietary Assn. |
Proposed
Labeling |
070278 |
Vick Divisions
Research |
Resorcinol |
070279 |
Vick Divisions
Research |
Antibacterial
activity and protocol for in vivo testing |
070280 |
Vick Divisions
Research |
Prevention of
new acne lesions |
070281 |
Ketchum Labs.
Inc. |
Propa pH Super
Cleaner |
070282 |
Sterling Drug
Inc. |
Stri-dex |
070283 |
Upjohn Co. |
Plexion |
070284 |
Vicks
Divisions Research |
Resorcinol |
070285 |
Vick Divisions
Research |
In vitro
protocol |
070286 |
Sterling Drug
Inc. |
Salicylic Acid |
070287-8 |
Koppers Co. |
Resorcinol |
070289 |
Stiefel Labs,
Inc. |
Benzoyl
peroxide and sulfur |
070290 |
Vick Divisions
Research |
Resorcinol |
070291 |
Dermik Labs |
Vlemasque |
070292 |
|
Presentation
and submissions to Panel November 14-15, 1980 |
070293 |
The
Proprietary Assoc. |
Benzoyl
peroxide antimicrobial activity |
070294 |
Information,
Inc. |
Benzoyl
peroxide |
070295-296 |
|
Acne References,
Uncited |
070297-300 |
|
Acne
References, Cited |
07BPA1 |
|
Panel’s
Administrator’s File, Volume I - General |
07BPA2A&B |
|
Panel’s
Administrator’s File, Volume II - Minutes of Panel meetings |
07BPA3 |
|
Panel
Administrator’s File, Volume III - Correspondence File (1977 - 1979) |
07BPA4 |
|
Panel
Administrator’s File, Volume IV - Correspondence File (1980 - 1981) |
TFM VOLUME
07BTFM
Has been established for Topical Acne
Drug Products
Topical Antifungal Drug Products for OTC Human
Use
Establishment of a Monograph and Reopening of
Administrative Record
Docket No. 80N-0476
Volume
07APA5
In the FEDERAL REGISTER of September 7, 1982 (47
FR 39464), the administrative record for the OTC topical antifungal drug
products rulemaking was reopened to include a statement on OTC Drug Products
for the Treatment of Diaper Rash by the Advisory Review Panel on OTC
Miscellaneous External Drug Products. To
avoid duplication, the Public Administrative File for that statement appears as
part of the administrative file for the OTC external analgesic drug products
rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982
(47 FR 39412).
The material included in the topical anitfungal rulemaking is identified in OTC Volume 06BPA6 in the external analgesic administrative file.
Public Administrative File
OTC
Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
080015 080016 |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid |
080043 |
Rystan Co.,
Inc. |
Chloresium
Toothpaste, Dental Ointment, Solution |
080050 |
Carter
Products |
Hydrogen
Peroxide |
080063 |
A-Trol
Laboratories |
I.D. Denture
Medication |
080071 |
McKesson
Laboratories |
Ora-Fix |
080072 |
McKesson
Laboratories |
Documented
Case Reports |
080094 |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid Additional Data |
080132 |
Carter
Products |
Aerodent Green
IV Dentifride |
080134B |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid Additional Data |
080140 |
Cooper
Laboratories, Inc. |
Amosan |
080144 080145 |
Warner-Lambert |
Listerine |
080147 |
Church &
Dwight Co., Inc. |
Sodium
Bicarbonate |
080156 |
Carter
Products |
Green IV Additional
Data |
080168 |
Rystan Co.,
Inc. |
Chloresium
Toothpaste, Dental Ointment, and Solution Additonal Data |
080175 |
Cooper
Lanboratories, Inc. |
Amosan Additional
Data |
080181 |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid Additional
Data |
080184 |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid Additional
Data |
080189 |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid Additional
Data |
080190 |
Merrell-National
Laboratories |
Cepacol
Mouthwash |
080219 |
Carter
Products |
Green IV Additional
Data |
080220 |
Cooper
Laboratories Inc. |
Amosan Additional
Data |
080244 |
Church &
Dwight Co., Inc. |
Sodium
Bicarbonate Additional
Data |
080247 |
Cooper
Laboratories, Inc. |
Amosan Additional
Data |
Public Administrative File
OTC
Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
SOURCE |
REMARKS |
|
080058 |
FDA |
NAS/NRC (DESI)
Reports. (Panel on
Drugs Used in Dentistry) |
080059 |
FDA |
Cross Index to
Data Submission. |
080061 |
FDA |
35th and 36th
Editions of “Accepted Dental Therapeutics” - Furnished at Panel’s Request. |
080064 |
FDA |
OTC Drug
Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid |
080065 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium F. Fluoride, General |
080066 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride |
080067 |
FDA |
OTC Drug
Literature Program X. Dentifrices Part-III (L-O) L. Sodium Monofluorophosphate M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride |
080106 |
FDA |
Color Additive Regulations-1974 (Requested by
Panel). |
080236 |
FDA |
Labels from
All Submissions. |
Public Administrative File
OTC
Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
Alphabetical Listing of
VOLUME |
|
080262 |
A-H |
080263 |
I-R |
080264 |
S-Z |
080265 |
Miscellaneous
Uncited References |
Public Administrative File
OTC
Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
Panel
Administrator’s File
VOLUME |
|
080PA1 |
Panel
Administrator’s File (Correspondence
File), Volume 1 Contents 1.0 Table of Contents 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Members 1.4 General and Specific Charges 1.5 List of Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and
Environmental Assessment
Report |
080PA2 |
Panel
Administrator’a File (Correspondence
File), Volume II, Meeting
Summary Minutes. |
080PA3 |
Panel
Administrator’s File (Correspondence
File), Volume III (1973-1978). |
Public Administrator’s File
OTC Anticaries Drug Products
Docket No. 80N-0042
VOLUME |
SUBMITTED BY |
|
080007 |
Whitehall
Labs, Inc. |
Super-white Kolynos
Toothpaste |
080008 |
The Lorvic
Corp. |
Coral II
Phosphate, Fluoride Prophylaxis
Paste |
080011 |
The Lorvic
Corp. |
Karidium Phosphate Fluoride
Topical Gel |
080012 |
The Lorvic
Corp. |
Karidium
Phosphate Fluoride
Topical Solution |
080018 080019 |
Lever Brothers |
Aim Stannous Fluoride
Toothpaste |
080022 |
Proctor &
Gamble Co. |
Gleen II
Toothpaste |
080023 |
Proctor &
Gamble Co. |
Crest
Toothpaste |
080030 |
Sterling Drug
Co. |
Caroid Tooth
Powder |
080031 |
Sterling Drug
Co. |
Phillips
Toothpaste |
080040 080041 |
Beecham
Products |
|
080043 |
Rystan Co.,
Inc. |
Chloresium
Toothpaste Dental
Ointment Solution |
080049 |
The Lorvic
Corp. |
Karidium
Phospate Fluoride
Topical Gel and Solution Additional
Data |
080052 |
Carter
Products |
Sodium
Fluoride Polymethylmethacrylate |
080053 |
Carter
Products |
Dicalcium
Phosphate |
080056 |
Dr. Lester D.
Apperson (CTFA Liaison
Rep.) |
Dentifrices |
080057 |
Lorvic Corp. |
Stannous
Fluoride |
080058A |
FDA |
Status of
Topical Fluoride
Preparations |
080060 |
American
Pharmaceutical Association |
Fluoride
Dentifrices |
080062 |
NDK Company |
NDK Dentifrice |
080083 |
|
Vademecum Chewing Gum |
080092 |
Dr. Lester D.
Apperson (CTFA Liaison
Rep.) |
Sodium
Fluoride |
080097 |
Proctor &
Gamble Co. |
Anticaries
Agents |
080098 |
Proctor &
Gamble Co. |
Crest
Toothpaste |
080099 |
Proctor &
Gamble Co. |
Gleem II Toothpaste |
08 0102 |
Janar Co.,
Inc. |
Iradicav |
080103 |
Dr. Lester D.
Apperson (CTFA Liaison
Rep.) |
Sodium
Monofluoro-phosphate Dentifrices |
080109 |
Warner lambert |
Sodium
Fluoride Rinse Additional
Data |
080115 |
FDA |
Workshop on
Fluorides and Dental Caries Reduction |
080118 |
Proctor &
Gamble Co. |
Stannous
Fluoride Dentifrices |
080119 |
Colgate-Palmolive |
Sodium
Monofluoro-phosphate Dentifrices Additional
Data |
080123 |
Beecham
Products |
Additional
Data |
080126 |
Beecham
Products |
Additional
Data |
080127 |
Lever Brothers |
Aim Stannous Fluoride
Toothpaste |
080128 |
Colgate-Palmolive |
Fluoride
Dentifrice |
080131 |
Church &
Dwight |
Arm &
Hammer Baking Soda, Arm & Hammer Toothpaste |
080133 |
Beecham
Products |
Additional
Data |
080134 080134A |
Colgate-Palmolive |
Sodium
Fluoride Sodium
Bicarbonate Dentifrice Additional
Data |
080135 080136 |
Warner lambert |
Acidulated
Fluoride-Phosphate Mouth Rinse |
080137 |
Beecham
Products |
Additional
Data |
080138 |
Colgate-Palmolive |
Sodium
Monofluoro-phosphate |
080139 |
Proctor &
Gamble Co. |
Crest
Toothpaste |
080141 |
Warner lambert
|
DiCal Chewing
Gum |
080141A |
Warner lambert |
DiCal Chewing
Gum |
080142 |
Lever Brothers |
Fluoride
Dentifrices Testing |
080143 |
Warner Lambert |
DiCal Chewing
Gum |
080143B |
Warner Lambert |
DiCal Chewing
Gum |
080146 |
Perident Co.,
Inc. |
Perident Salt
Toothpaste |
080148 |
Janar Co.,
Inc. |
Iradicav Additional
Data |
080149 080150 |
Warner Lambert |
Stannous
Fluoride Mouthrine
Tablet |
080152 |
CTFA - PA Dentifrice
Task Force |
Agents Used to
Formulate Dentifrices |
080153 |
Lever Brothers |
Silica Based
Dentifrice Containing NaMFP Additional
Data |
080154 |
Colgate-Palmolive |
MFP
Dentifrices Additional
Data |
080155 |
CTFA - PA |
Fluoride
Dentifrices |
080155A |
Dentifrice
Task Force |
|
080159 |
Beecham
Products |
Fluoride Dentifrice Additional
Data |
080160 |
Warner Lambert
|
DiCal Chewing
Gum |
080168 |
Rystan Co.,
Inc. |
Chloresium
Toothpaste Dental
Ointment and Solution Additional
Data |
080173 |
CTFA - PA Dentifrice
Task Force |
Laboratory
Profile on Fluoride Dentifrices |
080174 |
Colgate-Palmolive |
Colgate Dental
Cream |
080176 |
Beecham
Products |
Fluoride
Dentifrices |
080177 |
Lever Brothers
|
Laboratory
Profile on Fluorides |
080178 |
Proctor &
Gamble Co. |
Laboratory
Profile on Fluorides |
080179 |
Warner Lambert |
DiCal Chewing
Gum |
080182 |
Lever Brothers |
Aim Stannous Fluoride
Toothpaste Additional |
080185 |
Colgate-Palmolive |
Silica/MFP Dentifrices |
080192 |
Colgate-Palmolive |
Abrasive/MFP Combination |
080194 |
Colgate-Palmolive |
Sodium
Bicarbonate/ Sodium
Fluoride |
080195 |
Carter
Products |
Fluoride in
Polymethylmethacrylate-Based Dentifrice Additional
Data |
080197 |
Warner Lambert
|
Fluoride
Mouthrinses |
080199 |
|
Vademecum Sugarless Gum Additional
Data |
080200 |
Lever Brothers |
Aim Stannous Fluoride Tooth
paste Additional
Data |
080201 |
Colgate-Palmolive |
Dentifrice
Definitions |
080202 |
Carter
Products |
Pearl Drops Dentifrice |
080204 |
Lever Brothers |
Aim Stannous Fluoride
Toothpaste Additional
Data |
080205 |
Carter
Products |
Dentifrice
Definitions |
080206 |
Proctor &
Gamble Co. |
Dentifrice
Definitions |
080207 |
Beecham
Products |
Dentifrice
Definitions |
080209 |
Lever Brothers |
Stannous
Fluoride Silica Gel |
080210 |
Lever Brothers |
Fluoride
Dentifrices |
080215 |
Colgate-Palmolive |
Fluoride
Dentifrices Additional
Data |
080217 |
Lever Brothers |
MFP Silica
Based Dentifrice Additional
Data |
080232 |
Lever Brothers |
Aim Stannous Fluoride
Toothpaste Additional
Data |
080233 |
Lever Brothers |
Fluoride
Dentifrice Testing |
080235 |
Colgate-Palmolive |
Sodium
Monofluoro-phosphate Dentifrices |
080237 |
Proctor &
Gamble/PA task force |
Laboratory
Profiles on Fluorides |
080238 |
Lever Brothers |
Laboratory
Profiles on Fluorides |
080243 |
Proctor &
Gamble Co. |
Laboratory
Profiles on Fluorides |
080245 |
The
Proprietary Association |
Laboratory
Profiles on Fluorides |
080246 |
Church &
Dwight |
Sodium
Bicarbonate |
080248 |
The
Proprietary Association |
Standards for
Fluoride Dentifrices |
080249 |
Proctor &
Gamble Co. |
Crest
Toothpaste Gleem
Toothpaste |
080251 |
Lever Brothers
|
Proctor &
Gamble Co. Submission
080249 |
080253 |
The
Proprietary Association |
Reference
Formulations |
080256 |
Westwood
Research |
Testing
Procedures for Fluoride Dentifrices |
080260 |
Life Savers,
Inc. & CSR, Limited |
Calcium
Sucrose Phospate |
Public Administrative File
OTC
Anticaries Drug Products
(Docket No. 80N-0042)
General
Dental Submissions
SOURCE |
REMARKS |
|
080058 |
FDA |
NAS/NRC (DESI)
Reports. (Panel on
Drugs Used in Dentistry) |
080059 |
FDA |
Cross Index to
Data Submission. |
080061 |
FDA |
35th and 36th
Editions of “Accepted Dental Therapeutics”--Furnished at Panel’s Request. |
080064 |
FDA |
OTC Drug
Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid |
080065 |
FDA |
OTC Drug Literature
Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium Phosphate F. Fluoride, General |
080066 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride |
080067 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part III (L-O) L. Sodium N-Lauroyl M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride |
080106 |
FDA |
Color Additive Regulations-1974 (Requested by
Panel). |
080236 |
FDA |
Labels from
All Submissions. |
Public Administrative File
OTC Anticaries Drug Products
(Docket No. 80N-0042)
Alphabetical Listing of
References Cited in
Report
VOLUME |
|
080266 |
A-F |
080267 |
G-H |
080268 |
I-M |
080269 |
N-Z |
080270 |
Miscellaneous
Uncited References |
Public Administrative File
OTC Anticaries Drug Products
(Docket No. 80N-0042)
Panel Administrator’s File
VOLUME |
CONTENTS |
08APA1 |
Panel Administraotr’s
File, Volume I -
General 1.1 Calls for Data 1.2 List of Panel Memebrs and Liaisons 1.3 Curriculum Vitae for Panel Members
and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and
Environmental Assessment
Reprot |
08APA2 |
Panel
Administrator’s File, Volume II -
Minutes of Panel Meetings |
08APA3 |
Panel
Administrator’s File, Volume III -
Correspondence File, (1972-1974). |
08APA4 |
Panel
administrator’s File, Volume IV -
Correspondence File, (1975-1976). |
08APA5 |
Panel
Administrator’s File, Volume V -
Correspondence File, (1977-1979).. |
Public Administrative File
OTC Drug Products For the Relief of
Oral Discomfort
(Docket No. 80N-0228)
VOLUME |
SUBMITTED BY |
TRADE NAME/SUBJECT |
080001 |
Abbott
Laboratories |
Butyn Metaphen Dental
Ointment |
080002 |
Eneglotaria
Medicine Co., Inc. Of |
Gotas Dentil, Erpen |
080003 |
C.S. Dent
& Co. |
Dent’s
Toothache Drops
Treatment, Dent’s Toothache
Gum, Dent’s
Lotion-Jel, Dent’s Dental
Poultice |
080010 |
The Lorvic
Corp. |
Desensitizer |
080013 |
Denver
Chemical Manufacturing Co. |
Pain-A-Lay |
080014 |
Zelite Corp. |
Dent-Zelite |
080017 |
Vick Chemical
Co. |
Benzodent |
080028 |
K.I.K. Co. |
Cheramist # 30 |
080032 |
John Arthur
Geyer Co. |
Kank-A |
080033 |
Block Drug Co.
Inc. |
Sensodyne |
080034 |
Denver
Chemical Manufacturing Co. |
Dr. Hand’s
Teething Lotion, Dr. Hand’s
Teething Gel |
080035 080036 080037 |
Norwich
Pharmacal Co. |
Chloraseptic
Mouthwash and Gargle, Chloraseptic Lozenges, Chloraseptic
Aerosol Spray |
080042 |
Pfizer, Inc. |
Thermodent |
080048 |
Commerce Drug
Co., Inc. |
Ora-Jel, Baby Ora-Jel, Ora-Jel D |
080052 |
Carter-Wallace,
Inc. |
Sodium
Fluoride General Safety
and Efficacy Data |
080054 |
Sterling Drug,
Inc. |
Campho-Phenique |
080055 |
Whitehall
Laboratories, Inc. |
Anbesol |
080057 |
Dr. Robert
Stearns (Lorvic Corp.) |
Article on
Stannous Fluoride |
080060 |
AphA |
Letter of
5-21-73 Regarding
Fluoride Dentifrices |
080063 |
A-trol
Laboratories |
I.D. Denture
Medication |
080064 |
FDA |
FDA Literature Search Dental Products
Abstracts |
080070 |
Zelite Corp. |
Dent-Zelite Additional
Data |
080071 080072 |
McKessan
Laboratories |
Ora-Fix-M |
080073 |
Zelite Corp. |
Dent-Zelite Additional
Data |
080081 |
Block Drug
Co., Inc. |
Jiffy
Toothache Drops |
080084 |
Eaton Labs. Div. Of
Morton-Norwich Products, Inc. |
Chloraseptic
Mouthwash and Gargle Additional
Data |
080085 |
International
Pharmaceutical Corp. |
DeSense Dental
Gel |
080086 |
American
Dental Association |
Data on
Toothache Preparations |
080089 |
Sterling Drug,
Inc. |
Campho-Phenique Additional
Data |
080093 |
Sterling Drug,
Inc. |
Campho-Phenique Additional
Data on Rationale for
Inclusion of Camphor |
080095 |
International
Pharmaceutical Corp. |
Protect Dental
Gel |
080101 |
Whitehall
Laboratories, Inc. |
Anbesol Additional
Data |
080107 |
International
Pharmaceutical Corp. |
Protect Dental
Gel Additional
Data |
080112 |
Warner Lambert
Co. |
Thymol Additional
Data |
080114 |
Commerce Drug
Co. |
Ora-Jel Additional
Data |
080117 |
International
Pharmaceutical Corp. |
Protect Dental
Gel Additional
Data and Protocol
for a Clinical Study |
080118 |
Colgate-Palmolive
Co. |
Additional
Data (Stability) |
080119 |
Colgate-Palmolive
Co. |
Additional
Data on Sodium Monoflurophosphate |
080125 |
Whitehall
Laboratories, Inc. |
Anbesol Additional
Formulation Data |
080128 |
Colgate-Palmolive
Co. |
Suggested
Guidelines for Fluoride Dentifrices |
080152 |
CTFA-PA Dentifrice
Task Force |
Agents Used to
Formulate Dentifrices |
080173 |
CTFA-PA Joint Task
Force |
Summary of
Laboratory Profile on Fluoride Dentifrices |
080174 |
Colgate-Palmolive
Co. |
Sodium
Monofluorophosphate Summary of
Laboratory Profile |
080176 |
Beecham
Products, Inc. |
Data on
Fluoride Dentifrice Expiration
Dating |
080177 |
Lever Brothers |
Data on
Fluoride Laboratory Testing Profile and Expiration Dating |
080178 |
Procter and
Gamble Co. |
Data on
Laboratory Testing Profile for Fluoride |
080180 |
The Rilox Coo. |
Creole
Toothpaste Wax |
080191 |
Block Drug
Co., Inc. |
Poloris Dental
Poultice |
080193 |
Whitehall
Laboratories, Inc. |
Comments on
Proposed Ethanol Limits |
080198 |
Block Drug
Co., Inc. |
Sensodyne Additional
Data |
080210 |
Lever Brothers |
Formulation
Changes for Fluoride Dentifrices |
080211 080212 080213 |
Abbott
Laboratories |
Butyn Dental
Ointment Additional
Studies |
080214 |
Block Drug
Co., Inc. |
Poloris Dental
Poulice Additional
Data |
080216 |
Glenbrook Labs., Div. Of
Sterling Drug, Inc. |
Campho-Phenique Additional
Data |
080221 080222 |
|
Protect Dental
Gel Additional
Data |
080223 |
Proprietary
Association |
Protocol
Guidelines for Densensitizing Dentifrices |
080224 |
Block Drug
Co., Inc. |
Sensodyne Additional Efficacy
Data |
080225 |
Marion
Laboratories, Inc. |
Protect Dental
Gel Additional
Safety Data on Pluronic Polyolis in General, Pluronic F-127
and Efficacy Data |
080226 |
Block Drug
Co., Inc. |
Comparative
Active and Placebo Formulation Data |
080227 |
BASF Wyandotte
Corp. |
Toxicity Data
on Pluronic Polyols |
080229 |
Vick Chemical
Co. |
Potassium
Nitrate Toothpaste |
080230 |
Vick Chemical
Co. |
Potassium
Nitrate Toothpaste Testing
Methodology |
080231 |
Vick Chemical
Co. |
Potassium
Nitrate Toothpaste Testing
Methodology Proposed Protocol |
080237 |
Proctor and
gamble Co./PA Task Force |
Fluoride
Profiles |
080238 |
Lever Brothers |
Fluoride
Laboratory Profile Tests |
080239 |
Proprietary
Association |
Protocol for
Testing Tooth Desensitizers |
080240 |
Proprietary
Association |
Presentation
on Tooth Desensitizer Testing |
080241 |
Vick Chemical
Co. |
Status of
Potassium Nitrate as a Tooth Desensitizer |
080243 |
H.V. Shuster
& Co. |
Stannous
Fluoride/IMP Laboratory Profile |
080245 |
PA Task Force |
Fluorides
Laboratory Profile |
080248 |
PA Task Force |
Standards for
Fluoride Dentifrices |
080250 |
Sanlor
Laboratories |
Endoflas, F.S. |
080250A |
Sanlor
Laboratories |
Endoflas, F.S.
Appendix |
080252 |
Marion
Laboratories, Inc. |
Protect Dental
Gel Additional
Data |
080253 |
PA Subgroup on
Fluoride Dentifrices |
Fluoride
Dentifrices Reference
Formulations |
080254 |
Sanlor
Laboratories |
Endoflas, F.S. Additional
Data |
080255 |
Commerce Drug
Co., Inc. |
Baby Ora-Jel Additional
Data |
080256 |
Westwood
Research Lab |
Testing
Procedures on Fluoride Dentifrices |
080257 |
Block Drug
Co., Inc. |
Sensodyne New Clinical
Study |
080258 |
Whitehall
Laboratories, Inc. |
Anbesol Additional
Data |
080259 |
Vick Chemical
Co. |
Testing Method
for Tooth Desensitizers Additional
Data |
Public Administrative File
OTC Drug Products for the Relief of Oral Discomfort
(Docket No. 80N-0228)
Genreal Dental Submissions
VOLUME |
SOURCE |
REMARKS |
080058 |
FDA |
NAS/NRC (DESI)
Reports. (Panel on
Drugs Used in Dentistry) |
080059 |
FDA |
Cross Index to
Data Submission. |
080061 |
FDA |
35th and 36th
Editions of “Accepted Dental Therapeutics”--Furnished at Panel’s Request. |
080064 |
FDA |
OTC Drug
Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid |
080065 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices’ C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium Phosphate F. Fluoride, General |
080066 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride |
080067 |
FDA |
OTC Drug
Literature Program X. Dentifrices-Part III (L-O) L. Sodium Monofluoro- phosphate M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride |
080106 |
FDA |
Color Additive Regulations-1974 (Requested by
Panel). |
080236 |
FDA |
Labels from
All Submissions. |
Public Administrative File
OTC Drug Products for the relief of Oral Discomfort
(Docket No. 80N-0228)
Alphabetical Listing of
References Cited in Report
VOLUME |
CONTENTS |
080271 |
A-F |
080272 |
G-P |
080273 |
Q-Z |
080274 |
Miscellaneous
Uncited Reference |
Public
Administrative File
OTC Drug Products for the Relief of Oral Discomfort
(Docket No. 80N-0228)
Panel Administrator’s File
VOLUME |
CONTENTS |
08BPA1 |
Panel
Administrator’s File, Volume I -
General 1.1 Calls for Data 1.2 List of Panel Memebrs and Liaisons 1.3 Curriculum Vitae for Panel Members
and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions 1.6 Minutes of Panel Meetings |
08BPA2 |
Panel
Administrator’s File Volume II -
Correspondence File, (1972-1982). |
LAXATIVE, ANTIDIARRRHEAL, EMETIC,
ANTIEMETIC
OVER THE COUNTER DRUGS, DATA
SUBMITTED FOR REVIEW
VOLUME |
SUBMITTED BY |
TRADE NAME |
INGREDIENTS LISTED |
CLAIMS |
090001 |
Lewis-Howe
Company |
Concentrated
Milk of Magnesia |
Milk of
Magnesia |
As a Laxative |
090002 |
Combe Inc. |
Espotabs |
Yellow
Phenolphthalein |
As a laxative |
090003 |
Lewis-Howe Co. |
Nature’s
Remedy Regular; Nature Remedy
Candy Coated; Nature’s Remedy Juniors |
Aloe, Cascara
Sagrada |
A dependable,
all vegetable, family laxative for the relief of occasional constipation |
090004 |
Riker labs. |
Dorbane Dorbantyl Dorbantyl
Forte |
Danthron |
Promotes
colonic peristalsis and is a superior laxative in the management and
treatment of constipation. |
090005 |
Merrick
Medicine Company |
Percy Medicine |
Bismuth Subnitrate Rhubarb
Fluidextract Potassium
Carbonate Calcium
Hydroxide |
As
antacid-Astrigent for simple diarrhea and temporary relief of gastric
discomfort due to overeating or other dietary indiscretions. |
090006 |
ICI America
Inc. |
Dialose Dialose Plus Effersyllium
Instant Mix |
Dioctyl Sodium Sulfosuccinate Sodium
Carboxymethylcell-ulose Casanthranol |
For treating
constipation due to hardness or lack of moisture in the intestinal contents,
an effective fecal softener whose action will help to restore normal bowel
function gradually, without griping or acute discomfort. |
090007 |
Burton,
Persons & Company |
|
Psyllium
Hydrophilic Mucilloid |
|
090008 |
Burton,
Parsons & Company |
Psyllium
Hydrophilic Mucilloid with
Dextrose |
Psyllium
Hydrophilic Mucilloid with
Dextrose |
|
090009 |
Burton,
Parsons & Company |
Konsyl |
Psyllium
Hydrophilic Mucilloid |
Provides a
bland non-irritation bulk and lubricating effect to promote normal
elimination. |
090010 |
C.B. Fleet
Company, Inc. |
Fleet Enema Fleet Enema
Pediatric |
Sodium
Biphosphate Sodium
Phosphate Monosodium
Phosphate Disodium
Phosphate |
|
090011 |
C.B. Fleet
Company, Inc. |
Fleet Buffered
Laxative Fleet Buffered
Laxative, Flavored |
Sodium
Biphosphate Monosodium
Phosphate Sodium
Phosphate Disodium
Phosphate |
Gentle
regulated and predictable elimination. |
090012 |
National
Magnesia Co., Inc. |
National
Solution of Citrate of Magnesia |
Anhydrous
Tribasic Magnesium Citrate, Anhydrous Citric Acid, Anhydrous Tribasic Sodium
Citrate |
Alkalizing
laxative. |
090013 |
Wyeth
Laboratories, Inc. |
Petrogalar
Plain Phenolphthalein
Petrogalar Cascara
Petrogalar Glycerine
Suppositories Adult Glycerine Suppositories
Children |
Aqueous
Suspension of Mineral Oil Phenolphthalein
in Aqueous Suspension Mineral Oil Cascara
Sagrada in an Aqueous Suspension of Mineral Oil Glycerine
Suppositories Glycerine
Suppositories |
Laxative Laxative Use of
Glycerin Suppositories will be found more convenient than enemas and more
rapid in action than purgatives given by mouth. |
090014 |
Wyeth
Laboratories, Inc. |
Kaomagma Kalpac Polymagma
plain Polymagma
Plain Tablets |
Kaolin in
Alumina Gel Kaolin in
Alumina Gel with Pectin Activated
Attapulgite, Pectin Activated
Attapulgite, Pectin Hydrated Alumina Powder |
For the
control of Diarrhea an activated fluid adscrbent Control of
diarrhea |
090015 |
U.S.V.
Pharmaceutical Corporation |
Neo-Cultol |
Mineral Oil
Jelly |
For intestinal
lubrication as a gentle corrective in constipation. |
090016 |
U.S.V.
Pharmaceutical Corporation |
Bacid |
Lactobacillus
Acidophilus Sodium
Carboxymethyl Cellulose |
Relief of
diarrhea and associated renal discomfort. |
090017 |
Dorsey
Laboratories |
Vacuetts
Suppositories |
Sodium
Biphosphate Anhydrous Sodium Acid
Pyrophosphate Sodium
Bicarbonate |
For bowel
evacuation of the lower bowel in most common types of constipation. Vacuetts are
non-irritating to rectal mucosa and non-habit forming. |
090018 |
Abbott
Laboratories |
Maltsupex
Filmtab Maltsupex |
Malt Soup
Extract Malt Soup
Extract Solids |
A natural
corrective for chronic constipation, laxative dependence and rectal
itching. Effective, non-habit forming,
it promotes soft, easily passed stools. |
090019 |
Abbott
Laboratories |
Syllamalt
Powder |
Malt Soup
Extract Blond Psyllium
Seed Husks |
Natural barley
extract and psyllium seed husks are combined to promote bowel regulatory.
Effective, non-habit forming. |
090020 |
Abbott
Laboratories |
Syllamalt
Effervescent |
Malt Soup
Extract Powder Blond Psyllium
Seed Husks |
Promotes bowel
regularity. Soften stools and serves
to provide bulk. |
090021 |
Pharmaseal
Laboratories, Inc. |
Sigmol Enema |
Sorbitol USP Dioctyl
Potassium Sulfosuccinate |
Sodium-Free Non-irritating. |
090022-090023 |
Warren-Teed
Pharmaceuticals Inc. |
Modane Modane, Mild |
Dathron d-Calcium
Pantothenate |
Laxative |
090024 |
Lacto Products
Company |
Acidophilus
Concentrate |
Lactobacillus
Acidophilus |
Used to change
the bacterial flow of the intestinal tract. |
090025 |
|
Rectalad Enema |
Glycerin Diotyl
Potassium Sulfosuccinate |
To relieve
occassional or temporary constipation. |
090026 |
Whitehall
Laboratories Inc. |
Preparation H
(Non-Laxative Regulator) |
Dioctyl Sodium
Sulfosuccinate |
Softens dry
hard stools for easier, more comfortable passage. |
090027 |
Warner-Lambert
Company |
Veracolate |
Bile Salts Phenolphthalein Ext. Cascara
Sagrada Oleoresin
Capsicum |
Temporary
relief of constipation. |
090028 |
Warner-Lambert
Company |
Veracolate |
Bile Salts Phenolphthalein Ext. Cascara
Sagrada Oleoresin
Capsicum |
Temporary
relief of constipation. |
090029 |
Chattem Drug
and Chemical Company |
Black-Draught
Granulated Black-Draught
Senna-Lax Tablet Black-Draught
Powder Black-Draught
Syrup of |
Senna Senna Senna Senna |
Laxative Laxative Laxative Laxative |
090030 Vol. I |
J.B. Williams
Co., Inc. |
Serutan
Concentrated Powder |
Plantago Ovata
Husk Methyl Cellulose |
Aid to
regularity |
090031 Vol. II |
J.B. Williams
Co., Inc. |
Serutan
Concentrated Fruit Flavored |
Plantago Ovata
Husk Methyl Cellulose |
Aid to
regularity |
090032 |
J.B. Williams
Co., Inc. |
Serutan
Toasted Granules |
Plantago Ovata
Husk Methyl Cellulose |
Aid to
regularity |
090033 Vol. I 090034 Vol. II |
Ex-Lax, Inc. |
Ex-Lax
Chocolated Ex-Lax
Unflavored Ex-Lax Instant
Mix |
Yellow
Phenolphtalein Yellow
Phenolphtalein Yellow
Phenolphtalein |
Relief of
Constipation. Laxative. |
090035 |
The Upjohn
Company |
Imbicoll with
Cascara Imbicoll with
Vitamin B1 |
Vegetable Gum,
Cascara Sagrada Vegetable Gum,
Thiamine Hydrochloride |
Laxative
Bulk-producing aid. |
090036 |
The Upjohn
Company |
Phenolax
Wafers |
Phenolphthalein |
Relief of
constipation. |
090037 |
The Upjohn
Company |
Kaopectate Kao-Con |
Kaolin, Pectin Kaolin, Pectin |
Treatment of
diarrhea. |
090038 |
International
Pharmaceutical Corporation |
Dia-Quel
Liquid |
Tincture of
Opium, Homatropine Methlbromide, Pectin |
Rapid control
of diarrhea, relief of cramping, colickky pain and nausea, soothes and
protects intestinal tract. |
090039 |
Searle
Laboratories |
Metamucil powder Metamucil
instant Mix |
Psyllium
Hydrophyllic Mucilloid |
Treatment of
constipation, promotes natural elimination. |
090040 Vol. I |
Searle
Laboratories |
Dramamine |
Dimenhydrinate |
Prevent travel
sickness. |
090041 Vol. II |
Searle
Laboratories |
Dramamine
Liquid |
Dimenhydrinate |
Prevent travel
sickness. |
090042 Vol. I & 090043 Vol. II |
Hoechst
Pharmaceuticals, Inc. |
Doxan Doxidan Doxinate Doxinate
Solution Surfak |
Danthron,
Dioctyl Sodium Sulfosuccinate Danthron,
Dioctyl Calcium Sulfosuccinate Dioctyl Sodium
Sulfosuccinate Dioctyl Sodium
Sulfosuccinate Dioctyl
Calcium Sulfosuccinate |
Laxative with
stool softener an aid in the treatment of temporary constipation. |
090044 |
Beecham, Inc. |
ENO |
Sodium
Bicarbonate, Sodium Carbonate, Tartaric Acid |
Mild Laxative. |
090045 Vol. I & 090046 Vol. II |
A.H. Robins
Company |
Donnagel Donnagel |
Kaolin,
Pectin, Hyoscyamine Sulfate, Atropine Sulfate, Hyoscine Hydrobromide Kaolin,
Pectin, Hyoscyamine Sulfate, Atropine Sulfate, Hyosine Hydrobromide, Powdered
Opium, USP |
Mild Laxative. |
090047 |
Plough, Inc. |
Correctol |
Dioctyl Sodium
Sulfosuccinate Yellow Phenolphthallein |
Women’s gentle
laxative. |
090048 |
Plough, Inc. |
Saraka |
Frangula,
Sterculia |
All vetable laxative for planned regularity. |
090049 Vol. I 090050 Vol. II |
Plough, Inc. |
Feen-A-Mint Gum and Mints |
Yellow
Phenolphthalein |
|
090051 |
William H.
Rorer, Inc. |
Emetrol |
Levulose,
Dextrose, Ortho-phosphoric Acid |
For nausea and
vomiting. Relief of upset stomach and
nausea associated with Colds, Food indiscetions, emotional upsets and travel
discomfort. |
090052 Vol. I & 090053 Vol. II |
Norwich
Pharmacal Company |
Pepto-Bismol |
Bismuth
Subsalicylate Zinc
Phenolsulfonate |
Upset stomach,
indigestion, nausea and controls diarrhea. |
090054 Vol. I 090055 Vol. II 090056 Vol. III |
Norwich
Pharmacal Company |
Pepto-Bismol Chewable
Tablets |
Bismuth
Subsalicylate Precipitated
Calcium Carbonate, USP Glycocoll |
Relief for
upset stomach, ingestion, nausea, common diarrhea. |
090057 |
Whitehall
Laboratories, Inc. |
Petro-Syllium
plain Petro-Syllium
with Phenolphthalein |
Psyllium Seed,
NF Mineral Oil, Protol, USP |
Relief for constipation, softens hard stool and helps to move it
through the intestinal tract comfortably. Relief of
constipation, nonfattening liquid emulsion of mineral oil. Passes through stomach and upper intestine
without upset or dyhydrationg effect. |
090058 |
Sandoz
Pharmaceuticals |
Glysennid
Tablets |
Sennosides A
and B |
Laxative. |
090059 |
Cooper
Laboratories, Inc. |
Kondremul
Plain Kondremul with
Cascara Kondremul with
Phenolphthalein Neo-Kondremul |
Mineral Oil,
USP Mineral Oil,
USP Cascara Ext. Mineral Oil,
USP Phenolphthalein Mineral Oil,
USP Casathranol |
Laxative,
temporary relief of constipation. Relief of
constipation. Promotes normal bowel
movement, assures soft stool. Same as
Kondremul with Cascara. Temporary
relief of constipation, when severe symtoms of constipation have subsided,
satisfactory action will usually be obtained by changing to Kondremul plain. |
090060 |
Sterling Drug
Inc. |
Mucilose
Flakes Mucilose
Granules Mucilose
Powder |
Hemicellulose
of Psillium |
Special
formula to afford intestinal bulk and lubrication. |
090061 |
Sterling Drug
Inc. |
Haley’s M-O Mil-Par |
Milk of
Magnesia, USP Mineral Oil Milk of
Magnesia, USP Mineral Oil |
Gentle
laxative antacid lubricant. Same as
Haley’s M-O but in Spanish |
090062 |
Sterling Drug,
Inc. |
Sal Andrews Andrews Salts |
Tartaric Acid Sodium
Bicarbonate Magnesium
Sulfate Dihydrate |
Laxative |
090063 |
Sterling Drug,
Inc. |
Phillip’s Milk
of Magnesia Phillip’s Milk
of Magnesia Tablets |
Milk of
Magnesia Magnesium
Hydroxide |
Laxative Gives more
complete relief than single-purpose laxatives. Is an effective antacid as well as
laxative. |
090064 |
Sterling Drug,
Inc. |
Fletcher’s
Castoria |
Extract Senna |
Leading
laxative specially formulated for babies and growing children. |
090065 |
Sterling Drug,
Inc. |
Caroid and
Bile Salts |
Extract
Cascara Sagrada Phenolphthalein Desiccated
Whole Bile Caroid Capsicum |
When
Constipation occurs, caroid and bile salts help to restore a normal pattern
of elimination. They have been found
so safe and gentle that doctors have recommended their use for the relief of
constipation associated with pregnancy and in heart patients where straining
at the stool may cause a dangerous rise in blood pressure. |
090066 |
Pfizer
Pharmaceuticals |
Bonine |
Meclizine
Hydrochloride |
Prevent nausea
and vomiting of travel sickness. |
090067 |
Parke, Davis
& Company |
Alophen Pills Casacara
Sagrada Fluidextract-Aromatic Cascara
Sagrada Aromatic CAS-EVAC Kapseals
Desicol D-S-S Capsules D-S-S Plus Geriplex Geriplex FS
Liquid Glycerin
Suppositories Milk of
Magnesia |
Aloin, Extract
Belladona, Powdered Ipecac Phenolphthalein Cascara
Sagrada, USP Ground Cascara
Sagrada, USP Ground Cascara
Sagrada, USP Desiccated
Whole Fresh Bile Diotyl Sodium
Sulfosuccinate Diotyl Sodium
Sulfosuccinate, Casanthranol Vit. A Acetate, Vit. C, Thiamine Mononitrate, USP riboflavin,
USP Cyanocobalamin, Choline Dihydrogen Citrate NF Niacinamide, USP Vit. E,
Dioctyl Sodium Sulfosuccinate Thiamine
Hydrochloride Vit. B2, Pyridoxine Hydrochloride, Cyanocobalamin Niacinamide,
Iron, Pluronic F-68 Glycerin Magnesium
Hydroxide |
Temporary
relief of occasional constipation. Laxative. Laxative. Laxative. Laxative. Stool
softener. Laxative and
stool softener. Vit./Min. formula with fecal softener. Geriatic Vit.
Tonic with iron and a fecal softener. Laxative,
afford a quick method of emptying the lower bowel. Laxative. |
090067 (cont.) |
|
Pargel Siblin Siblin Tablets |
Kaolin, Pectin Psyllium Seed
Husks Thiamine
Hydrochloride, USP Psyllium Seed
Husk, Powdered Agar, USP Thiamine
Hydrochloride, USP |
Antidiarrheal
for treatment of diarrhea. Laxative, for
the relief of functional constipation. Laxative. A preparation for the relief of functional
constipation. |
090068 |
Carter-Wallace,
Inc. |
Carters Little
Pills |
Aloe, USP Podophyllum
Resin, USP |
Reduce the
following symtoms when due only to constipation: sluggishness, bloated
feeling, headache, nervous-ness. |
090069 |
William H.
Rorer, Inc. |
Parepectolin |
Paregoric,
Pectin Kaolin |
Anti-diarrheal. |
090070 |
received (May
8, 1973) The Upjohn
Company |
Hydrolose
Syrup |
Methylcellulose |
Aid to bowel
regularity |
090071 |
The Upjohn
Company |
Bile Salts
Phenol-phthalein Compound |
Bile Salts,
Phenolphthalein, Papain, Ext. Cascara Sagrada, Ginger |
Temporary
relief of constipation |
090072 |
The Upjohn
Company |
Casakol
Capsules |
Poloxalkol,
Casanthranol |
Temporary
relief of occasional constipation |
090073 |
The Upjohn
Company |
Casyllium |
Cascara,
Psyllium Husk Powder, Prune Powder |
Bulk-Producing
preparation with added laxatives |
090074 |
The Upjohn
Company |
Polykol |
Poloxalkol |
Temporary
relief of hard stools |
090075 |
Scott
Laboratories, Inc. |
Caster Oil Glycerine Citrate of
Magnesia |
Caster Oil Glycerine Citrate of
Magnesia |
Used as an
emollient As an active
purgative |
090076 |
Merit Remedy
Company |
Gall - Solve Merit
Cathartics |
Oxgall, Sodium
Oleate Phenolphthalein Cascara,
Aloin, Podophyllin Oleoresin, Ginger |
A cholagogue
mild laxative to stimulate the flow of bile, recommended for constipation,
headaches or biliousness due to constipation Temporary
relief of occasional constipation |
090077 |
The Purdue
Frederick Company |
Senokot
Granules |
Senna
Concentrate |
Gentle bowel
stimulation aiding laxation relieves constipation |
090078 |
The Purdue
Frederick Company |
Senokot
Tablets |
Senna
Concentrate |
Relieves
constipation |
090079 |
Miles
Laboratories, Inc. |
Decholin |
Dehydrocholic
Acid |
Digestive Aid,
Laxative. Indigestion-after meal
discomfort & fullness (particularly after fatty meals) - excessive
belching-constipation |
090080 |
Gray Pharmacal
Co. |
X-Prep Powder |
Senna
Concentrate |
For routine
preradiologic bowel evacuation |
090081 |
The Purdue
Frederick Co. |
Senokot
Suppositories |
Senna
Concentrate |
Rectal
laxative |
090082 |
Gray
Pharmaceutical Co. |
X-Prep Liquid |
Senna fruit
extract |
Preradiographic
bowel evacuant |
090083 |
The Purdue
Frederick Co. |
Gentlax S |
Senna
Concentrate Dioctyl sodium
sulfosuccinate |
For gentle,
reliable relief of constipation |
090084 |
The Purdue
Frederick Co. |
Gentlax Tablet |
Senna
Concentrate Guar gum |
A gentle
laxative, for relief of simple constipation |
090085 |
The Purdue
Frederick Co. |
Gentlax
Granules |
Senna
concentrate Guar gum |
A gentle
laxative with bulk for relief of simple constipation |
090086 |
The Purdue
Frederick Co. |
Senokap DSS
Capsules |
Senna
concentrate Dioctyl sodium
sulfosuccinate |
Relieves
constipation, softens stool |
090087 |
The Purdue
Frederick Co. |
Senokot Syrup |
Extract senna
fruit |
Natural
vegetable laxative, relieves constipation |
090088 |
The Purdue
Frederick Co. |
Senokot with
Psyllium Powder |
Senna
concentrate Psyllium |
Laxative with
bulking agent for simple constipation |
090089 |
Marcen
Laboratories, Inc. |
Acelax Tablets |
Danthron Chondrus
crispus Dioctyl sodium
sulfosuccinate Prune
concentrate dehydrated |
|
090090 Vol. 1 |
Hynson,
Wesrcott & Dunning, Inc. |
Lactinex
Granules |
Lactobacillus
acidophilus Lactobacillus
bulgaricus |
Assist in
restoration & maintenance of normal intestinal flora, & to help
relieve the discomforts of diarrhea & fever blisters. |
090091 Vol. 2 |
Hynson,
Westcott & Dunning, Inc. |
Lactinex
Tablets |
Lactobacillus
acidophilus Lactobacillus
bulgaricus |
Assist in
restoration & maintenance of normal intestinal flora, & to help
relieve the discomforts of diarrhea & fever blisters. |
090092 |
E.R.Squibb
& Sons, Inc. |
C.T. Milk of
Magnesia Mint-O-Mag Milk of
Magnesia Glycerine
Suppositories Mineral Oil,
U.S.P. |
Magnesium
hydroxide Magnesium hydroxide Magnesium
hydroxide Glycerin Mineral oil |
Laxative,
antacid Antacid,
laxative Antacid,
laxative Laxative Intestinal
libricant |
090093 |
Hoechst
Pharmaceuticals Inc. Supplemental submission Vol. 1 |
Doxan tablets |
Addendum to
Volume 090042 |
|
090094 |
Hoechst
Pharmaceuticals, Inc. Same as above, Volume II |
|
|
|
090095 |
Eneglotaria
Medicine Co., Inc. Of |
Kao Gest |
Colloidal
kaolin, pectin |
For the
treatment of common diarrhea |
090096 |
The Purdue
Frederick Co. |
Parelixir
Liquid |
Tincture
opium, pectin alcohol |
Nonspecific
diarrhea |
090097 |
Miles
Laboratories, Inc. |
Decholin |
Addendum to
Volume 090079 |
|
090098 |
C.B. Fleet
Co., Inc. |
Fleet Enema |
Addendum to
Volume 090010 |
|
090099 |
Norwich
Pharmacal Co. |
Pepto Bismol |
Addendum to
Volume 090052 |
|
090100 |
|
Bran |
Bran |
|
090101 |
|
Bran |
Pharmacology
reports |
|
090102 |
|
Bran |
Reprints |
|
090103 |
|
Bran |
Reprints |
|
090104 |
Lewis Howe
Company |
Nature’s
Remedy |
Supplemental
submission on aloe |
|
090105 |
Lewis Howe
Company |
Nature’s
Remedy |
Supplemental
submission on aloe |
|
090106 |
Lewis Howe
Company |
Nature’s
Remedy |
Supplemental
submission on aloe |
|
090107 |
Lewis Howe
Company |
Nature’s
Remedy |
Supplemental
submission on aloe |
|
090108 |
American
Cyanamid Co. |
Dioctyl Sodium
Sulfosucinate |
(no trade
name) |
|
090109 |
In House
report for OTC Antiemetics |
|
|
|
090110 |
In House
report for Bisacodyl |
|
|
|
090111 |
In House
report for Guar Gum |
|
|
|
090112 |
E.R. Squibb
& Sons, Inc. |
Caster Oil |
Supplemental
labeling submission |
|
090113 |
Carter
Wallace, Inc. |
Carter’s
Little Pills |
Supplement to
Volume 090068 |
|
090114 |
Boehringer
Ingelheim Ltd. |
Dulcolax
Tablets Dulcolax
Suppositories |
Bisacodyl |
Laxative |
090115 |
Boehringer
Ingelheim Ltd. (Volume 2) |
|
|
|
090116 |
Boehringer
Ingelheim Ltd. (Volume 3) |
|
|
|
090117 |
|
Mel-O-Lax |
Magnesium
hydroxide |
|
090118 |
Bristol-Myers
Co. |
Sol Hepatica |
Sodium
bicarbonate Citric acid Monosodium
phosphate |
|
090119 Volume 1 |
Norwich
Pharmaceutical Co. |
Pepto Bismol |
Supplement to
Volume 090052 |
|
090120 |
Norwich
Pharmaceutical Co. |
Pepto Bismol |
Supplement to
Volume 090052 |
|
090121 |
The Upjohn
Company |
Kaolin -
pectin |
Supplement to
Volume 090037 |
|
090122 |
Parke Davis
Co. |
Alophen Pills |
Supplement to Vol. 090067 |
|
090123 |
Norwich
Pharmaceutical Co. |
Pepto-Bismol |
Supplement to Vol. 090052 |
|
090124 |
Merrick
Medicine Co. |
Rhubarb
Fluidextract |
Rhubarb |
|
090125 |
Upjohn Company |
Kaolin-pectin |
Supplement to Vol. 090037 |
|
090126 (Vol. 1) |
Merrell
National Laboratories |
Cephulac |
Lactulose
syrup (galactose and
lactose) |
|
090127 (Vol. 2) |
Merrell
national Laboratories |
Cephulac |
lactulose
syrup (galactose and
lactose) |
|
090128 |
Bristol-Myers
Products |
Bran tablets |
|
|
090129 |
Bristol-Myers
Products |
Bran tablets |
|
|
090130 |
Bristol-Myers
Products |
Bran tablets |
|
|
090131 |
Bristol-Myers
Products |
Bran tablets |
|
|
090132 |
Norwich
Pharmacal Co. |
Pepto-Bismol |
Supplement to Vol. 090052 |
|
090133 |
Pfizer |
|
Data
submission to Panel |
|
090134 |
Published
references cited in Panel Report |
|
|
|
090135 |
Communication
from Dr. Picchioni and copy of microfilm “Reference No. 8" cited in
Panel Report |
|
|
|
090136 |
Pfizer |
Bovine tablets |
|
|
090137 |
Pfizer |
Scopolamine
hydrobromide |
|
|
090138 |
Upjohn |
supplement to
090037 |
|
|
090139 |
Upjohn |
Supplement to
090037 |
|
|
090140 |
Hynson,
Westcott & Dunning, Inc. |
Lactinex |
Supplement to
090090 |
|
090141 |
Sterling Drug |
Haley’s M-O |
Supplement to
090061 |
|
090142 |
Assorted
Correspondence |
|
|
|
090143 |
Panel
Administrator’s File |
|
|
|
Ophthalmic Administrative File
OTC Ophthalmic Drug Products
(Docket No. 80N-0145)
VOLUME |
SUBMITTED BY |
|
100001 |
Flow
Pharmaceuticals, Inc. |
Hy-Flow,
aqua-Flow, Comfy, duo-Flow, d-Film, Trilisol |
100002 |
Riker
Laboratories, Inc. |
Bro-Lac,
Op-Isophrin, Wet-Tone |
100003 |
Julius Schmid,
Inc. |
Eyegenic Eye
Mist |
100004 100005 |
Julius Schmid,
Inc. |
Eye-Gene Eye
Drops |
100006 |
Abbott
Laboratories |
Murine |
100007 |
Burton,
Parsons & Company, Inc. |
Adsorbonac 2% |
100008 |
|
Adsorbonac 5% |
100009 |
|
Soothe |
100011 100012 |
Norwich
Pharmacal Company |
Ocusol Eye
Lotion, Ocusol eye
Drops |
100013 |
Wyeth
Laboratories, Inc. |
Collyrium
Soothing eye Lotion, Collyrium with Ephedrine Soothing Eye Drops |
100014 |
Professional
Pharmacal Company |
Bufopto Zinc
Sulfate |
100015 |
Professional
Pharmacal Company |
Efricel 1/8% |
100016 |
Professional
Pharmacal Company |
Neozin |
100017 |
Professional
Pharmacal Company |
Methulose,
Visculose |
100018 |
Barnes-Hind
Pharmaceuticals, Inc. |
Degest |
100019 |
Pfizer
Pharmaceuticals |
Visine Eye
Drops |
100020 |
Alcon
Laboratories, Inc. |
Contique
Contact Lens Wetting Solution, Lens-Mate |
100021 |
Alcon
Laboratories, Inc. |
Isopto Frin |
100022 |
Alcon
Laboratories, Inc. |
Naphcon |
100023 |
Alcon
Laboratories, Inc. |
Op-Thal-Zin |
100027 |
Alcon
Laboratories, Inc. |
Contique
Artificial Tears |
100030 |
Alcon
Laboratories, Inc. |
Zincfrin |
100031 |
Alcon
Laboratories, Inc. |
Estivin |
100032 |
Alcon
Laboratories, Inc. |
Isopto Tears,
Ultra Tears |
100033 |
Alcon
Laboratories, Inc. |
Eye-Stream |
100034 |
LaWall &
Harrisson Research
laboratories, Inc. |
20/20 Eye
Drops |
100035 100036 |
Abbott
Laboratories |
Clear Eyes |
100037 100038 100039 |
Cooper
Laboratories, Inc. |
Argyrol S.S., Goniosol, M-Z, Phenylzin,
Tear-Efrin, Tearisol |
100040 |
Allergan
Pharmaceuticals |
Lacril |
100041 |
Allergan
Pharmaceuticals |
Lacri-Lube
S.O.P. |
100043 |
Commerce Drug
Company, Inc. |
Ocu-Drop |
100044 |
Commerce Drug
Company, Inc. |
Stye |
100045 |
Commerce Drug
Company, Inc. |
Ocu-Bath |
100046 |
Alcon Laboratories, Inc. |
Contique Artifical
Tears Additional
Data |
100047 |
Allergan
Pharmaceuticals |
Pre-Sert |
100048 |
Abbott
Laboratories |
murine Additional
Data |
100050 |
Alcon Laboratories,
Inc. |
Contique
Dual-Wet Solution |
100051 |
Alcon
Laboratories, Inc. |
Lens-Mate |
100052 |
Alcon
Laboratories, Inc. |
Tears
naturale’ |
100053 100054 |
Mitchum-Thayer,
Inc. |
Mitchum’s Eye
Drops |
100055 |
Proprietary
Association |
Test Method
Used for All Purpose Contact Lens Solutions |
100056 |
Allergan
Pharmaceuticals |
Total |
100057 |
Schering
Corporation |
Documentation
in Support of Methylparaben and Propylparaben Comination Documentation
in Support of Sodium Thiosulfate Documentation
in Support of Tyloxapol |
100058 |
Alcon
Laboratories, Inc. |
General
Guidelines Applicable to the Evaluation of Lens Care Products |
100059 |
Allergan
Pharmaceuticals |
Blink-N-Clean |
100060 |
Allergan
Pharmaceuticals |
Liquifilm |
100061 |
Allergan
Pharmaceuticals |
Liquifilm
Tears |
100062 |
Allergan Pharmaceuticals |
Prefrin
Liquifilm Eye Drops |
100063 |
Allergan
Pharmaceuticals |
Prefrin-Z
Liquifilm |
100066 |
Allergan
Pharmaceuticals |
Comments and
Recommendations on Panel’s Summary Minutes |
100067 |
Alcon
Laboratories, Inc. |
Comments and
Recommendations on Panels’s Summary Minutes |
100068 |
Alcon
Laboratories, Inc. |
Additional
Comments on Cleaning and Wetting Agents |
100069 100070 100071 |
Flow
Pharmaceuticals |
hy-Flow,
aqua-Flow, Comfy, duo-Flow, d-Film, Trilisol Additional
data |
100072 |
Schering
Corporation |
Comment on 10%
Sulfacetamide and 2.3% Sodium Chloride Solution |
100073 |
Alcon
Laboratories, Inc. |
Supplemental
Data on Cleaning and Wetting Agents |
100074 |
Alcon
Laboratories, Inc. |
Additional
Studies Regarding Benzalkonium Chloride |
100075 |
Allergan
Pharmaceuticals |
Comments on
Warnings and Labeling |
100076 |
Allergan
Pharmaceuticals |
Additional
Information on “Preservative information” |
100078 |
Norcliff
Thayer, Inc. |
Safety
Protocol for 0.05% Naphazoline |
100079 |
K.C. Tsou,
Ph.D. |
Cytochemical
Methods |
100080 |
Allergan
Pharmaceuticals |
Data on “Draize” Testing Ethylene Oxide Testing,
and Buffering |
100081 |
Alcon
Laboratories, Inc. |
Estivin Additional
Data |
100082 |
Woody D.
Davis, M.D. |
Letter to
Panel on Stye Ointment |
100083 |
Norwich Pharmacal
Co. |
Supplemental
Information on Ocusol Eye Lotion and Comment on Eye |
100084 |
Flow
Pharmaceuticals |
Clerz |
100085 |
Alcon
Laboratories, Inc. |
Supplemental
Information on Hydroxypropylmethyl-cellulose |
100086 |
U.S.V.
Pharmaceutical Corp. |
Supplemental
Information on 0.05% Naphazoline |
100087 |
Allergan
Pharmaceuticals |
Methodology
for testing Safety, Effectiveness of Hard Contact Lenses. Data for Polyethylene glycol,
Polyoxylstearate, Polysorbate. Volumes
1 and 2 |
100088 |
Alcon
Laboratories, Inc. |
Benzalkonium
Chloride as a Preservative |
100089 100090 100091 100092 100093 |
Schering
Corporation |
Sulffacetamide
Data |
100094 |
U.S.V.
Pharmaceutical Corp. |
Naphazoline
Data: Dr. S. Morgan, Galin, U.S.V.
Letter October 21, 1975 |
100095 |
Allergan Pharmaceuticals |
Polyvinyl
Alcohol Data on Effectiveness as Wetting Agent |
100096 |
Ketchum
Laboratories |
Comments on
Preservative Test Guidelines |
100097 |
Calvin Hanna |
Data on 0.05%
Naphazoline |
100098 |
Allergan
Pharmaceuticals |
Data on the
use of Sodium Citrate in Lacril and Liquidifilm Forte |
100099 |
Alcon
Laboratories, Inc. |
Estivin Additional
Data |
100100 |
Alcon
Laboratories, Inc. |
Collaborative
Industry Study on the Effect of Serum on the Preservative Effectiveness of
Hard Contact Lens Solutions |
100101 |
Woody D. Davis,
M.D. |
Transcript of
Presentation to Panel on Stye Ointment |
101102 |
Proprietary
Association |
Statement on
FDA Policy on Exclususivity of Labeling Terms |
100103 |
Cooper
Laboratories, Inc. |
Recommendation
to the Panel to Allow Flexibility to Adjust Osmolarity for Ophthalmic
Products and Expansion of the List of Acceptable Polyethylene Glycols |
100104 |
Sherman
Laboratories, Inc. |
Aqueo-Rinse,
Dual-Clean Pena-Vel, Stay-Brite, Stay-Wet, Velva-Kleer |
100105 |
Commerce Drug
Company, Inc. |
Study on the
Safety and Efficacy of Mercuric Oxide Ointment for Relief of Sties and Minor
Infections of the Eyelids |
100106 |
Proprietary
Association |
Comments and
Recommendations on Panel’s Report |
100107 |
Medical
Library |
OTC Drug
Literature Program - Ophthalmic Preparations |
100108 |
Cooper
Laboratories, Inc. |
Additional
Information on Mild Silver Protein as an Anti-infective |
100109 |
Cooper
Laboratories, Inc. |
Comments on
Panel’s Summary Minutes |
100110 |
Cooper
Laboratories, Inc. |
Polyethylene
Glycol Additional Information |
100111 |
William H.
Havener, M.D. |
Comments on
Madatory OTC Drug Labeling |
Public Administrative File
OTC Ophthalmic Drug Products
(Docket No. 80N-0145)
Alphabetical Listing of
References Cited in Report
VOLUME |
CONTENTS |
100112 |
A - B |
100113 |
C - D |
100114 |
E - G |
100115 |
H - J |
100116 |
K - M |
100117 |
N - R |
100118 |
O:
“Ophthalmology Prescription Handbook” (only) |
100119 |
S |
100120 |
T - Z |
100121 |
Miscellaneous
Uncited References: A - E |
100122 |
Miscellaneous
Uncited References: F - H |
100123 |
Miscellaneous
Uncited References: I - R |
100124 |
Uncited
References: S: Smith, R.B. editor, “Anesthesia in
Ophthalmology” (only) |
100125 |
Miscellaneous
Uncited References: S - Z |
Administrative File
OTC Ophthalmic Drug Products
Docket No. 80N-0145
Panel Administrator’s File
10APA1 |
Panel
Administrator’s File, Volume I -
General 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members
and Liaisons 1.4 General and Specific Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment |
10APA2 |
Panel
Administrator’s File, Volume II -
Minutes of Panel Meetings. |
10APA3 |
Panel
Administrator’s File, Volume III -
Correspondence File, (1973-1980). |
OTC CONTRACEPTIVE SUBMISSIONS
(149A/0080A)
October
26, 1979
FIRM |
PRODUCT OR DATA |
||
110001 |
Center for
Science in the Public Interest FDA FDA |
Talc Literature
Search DESI publications |
|
110004 |
Holland Rantos
Co., Inc. |
Koromex
Contraceptive Jelly, Koromex
Contraceptive Cream, Korpmex
Contraceptive Jelly |
Boric acid,
phenylmercuric acetate “ ” “ ” Boric acid,
polyoxyethylene nonyl phenol, phenyl-mercuric acetate |
110005 |
Ortho
Pharmaceutical Corp. |
Ortho Gynol
Contraceptive Jelly |
p-Diisobutylphenoxypoly-ethoxyethanol |
110006 |
Ortho
Pharmaceutical Corp. |
Preceptin
Contraceptive Gel |
p-Diisobutylphenoxypoly- ethoxyethanol |
110007 |
Ortho
Pharmaceutical Corp. |
Ortho-Creme Contraceptive
Cream |
Nonoxynol-9 |
110012/14 |
Norwich
Pharmacal Co. NY 13815 Norwich
Pharmacal Co. NY 13815 |
Lorophyn jelly Lorophyn
Contraceptive Suppositories |
PMA,
octoxynol, methylparaben, sodium borate PMA,
methylbenzethonium chloride, methylparaben |
110016 |
Juluis Schmid,
Inc. |
Immolin
Contraceptive Vaginal Cream - Jel |
methoxypolyoxyethylene
glycol 550 Laurate Nonyl
phenoxypolyethoxy ethanol. |
110017 |
Juluis Schmid,
Inc. |
Finesse
Contraceptive Creme - gel |
methoxypolyoxyethylene
glycol 550 Laurate, nonoxynol-9 |
110018 |
Juluis Schmid,
Inc. |
Finesse
Contraceptive Creme - Gel |
Methoxypolyethylene
glycol 550 laurate,
nonoxynol-9 |
110020 |
Juluis Schmid,
Inc. |
Ramses
Contraceptive Vaginal Jelly |
Dodecaethylene
glycol mono-laurate, boric acid, alcohol |
110021 |
Holland
Rantoes Co., Inc. |
Improved
Koromex Contraceptive
Jelly |
Laureth 10S |
110026 |
Ortho Research
Foundation |
Selective
Bibliography on Vaginal Contraception and Therapeutics |
|
110028A |
Schmid
Laboratories Little Falls,
NJ 07424 |
Supp’l data;
Vagesic, Ramses jelly, Immolin cream
- jel |
|
110030 |
Schmid
Laboratories, Little Falls,
NJ 07424 |
Supp’l data;
Immolin and Finesse Contraceptives |
combo of
methoxypolyoxyethylene glycol 550
Laurate and Nonoxynol - 9 |
110033 |
Ortho
Pharmaceutical Corp. “ ” “ |
Rabbit Model
preprint 3 references lists re: spermphsiology and animal models for vaginal
contraceptives. |
|
110036 |
Emko Company |
Emko
contraceptive foam Because
contraceptive foam |
nonyl phenoxy polyoxyethylene ethanol. Benzethorium
chloride “ ” “ |
110040/41 |
Ortho
Pharmaceutical Corp. |
Vaginal
Contraceptive foaming tablet-safety and effectiveness |
Menfegol |
110045 |
Proprietary
Assn. |
OTC Labeling
Indications |
|
110049 |
Juliu Schmid,
Inc. |
Ramses |
Dodecaethylene
glycol monolaurate |
110050 |
Nova Corp of Cos |
Flavo-Cept.
Contraceptive jelly |
polyethylene
glycol 600
monolaurate (PEG-12 Laurate, Dodecaethylene glycol monolaurate |
110052 |
FDA |
Mercury
Correspondence |
|
110053 |
Ortho Research
Foundation |
Selective
Bibliography: 1975 Supplement to
Volume 110026 |
|
110055 |
The
Proprietary Assn. |
Comments on
the November 1978 “Information
Copy” - Panels Tentative Findings |
|
110056 |
|
Semicid: labeling presentation December 7,
1978 |
Nonoxynol-9 |
110058 |
FDA |
Cited
References (A-B) |
|
110059 |
FDA |
Cited
References (C-F) |
|
110060 |
FDA |
Cited
References (G-K) |
|
110061 |
FDA |
Cited
References (L-O) |
|
110062 |
FDA |
Cited
References (P-S) |
|
110063 |
FDA |
Cited References (T-Z) |
|
110064 |
FDA |
Uncited
References |
|
Administrative File
OTC
Vaginal Contraceptive Drug Products
Docket
No. 80N-0280
Panel
Administrator’s File
VOLUME |
CONTENTS |
11APA1 |
Panel
Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members
and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Interim Recommendation on Encare Oval 1.7 Regulatory Analysis Assessment 1.8 Statement of Exemption and
Environmental
Assessment Report 1.9 Requests for Confidentiality |
11APA2 |
Panel
Administrator’s File, Volume II - Minutes of Panel Meetings |
11APA3 |
Panel
Administrator’s File, Volume III - Correspondence File (1973-1974) |
11APA4 |
Panel
Administrator’s File, Volume IV - Correspondence File (1975-1977) |
11APA5 |
Panel
Administrator’s File, Volume V - Correspondence File (1978) |
11APA6 |
Panel
Administrator’s File, Volume VI - Correspondence File (1978-1979) |
VAGINAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO. 82N-0291)
INDEX
TO PANEL SUBMISSIONS
OTC VOLUME NUMBER |
SUBMITTED BY |
SUBJECT |
110001 |
Center for
Science in the Public Interest FDA FDA |
Talc Literature
Search DESI
Publications |
110002 |
Reed &
Carnrick Pharmaceuticals |
Tricotine
Powder Tricotine
Liquid |
110003 |
McKesson
Laboratories |
V.A. Douche
Powder |
110008 |
Chattem Drug
& Chemical Company |
Mata-Cine
Concentrated Douche Powder Pamprin
Concentrated Douche Powder |
110009 |
Rystan Company |
Prophyllin
Powder |
110010 |
Bristol-Myers
Company |
Feminique
Douche Liquid Concentrate |
110011 |
Block Drug
Company |
Femicare
Powder |
110015 |
Boyle and
Company |
Triva Douche
Powder |
110019 |
Juluis Schmid,
Inc. |
Vagesic Douche
Liquid Concentrate |
110022 |
Meri Jo. Inc. G.M. Case
Laboratories Phenex
Laboratories, Inc. |
Fine’s
Hygienic Powder PAF Douche
Powder Complete
Feminine Hygiene Antiseptic Deodorant Douche Phenex
Feminine Hygiene
Antiseptic Phenex Vaginal
Therapeutic Suppositories Phenex
Hygienic Suppositories |
110023 |
Purdue
Frederick Company |
Betadine
Douche |
110024 |
Norcliff
Laboratories, Inc. |
Zonite,
Zonitors |
110025 |
Beecham, Inc. |
Massengill
Liquid Douche |
110027 |
Wyeth
Laboratories, Inc. |
Propion Gel |
110028B |
Chattem Drug
& Chemical Company Louis Keit h,
M.D. |
Meta-Cine and
Pamprin Douche Powders Vaginal Odors Preprint and References |
110029 |
Beecham, Inc. Purdue
Frederick Company Rystan Company Wyeth
Laboratories, Inc. Young’s
DrugProducts |
Intravaginal
Administration of Boric Acid Betadine
Douche Prophyllin
Douche Propion Gel Polysorbate 20
as a Douche |
110031 |
R. Schattner
Company |
Gynaseptic
Vaginal Solution Gynaseptic
Vaginal Ointment |
110032 |
Beecham, Inc. |
Boric Acid |
110033 |
Ortho
Pharmaceutical Corporation |
Rabbit Model
Preprint Vaginal ph
References Guide to the
Physiological Suitability of Atlas Surfactants Cleansing
Properties of Pluronic F-68 Surfactants as
Vaginal Douches Three
Reference Lists Re: Sperm
Physiology and Animal Models for Vaginal Contraceptives |
110034 |
International
Playtex, Inc. |
Polysorbate 20
Safety Data |
110035 |
Vick Divisions
Research |
Douche Pipe
Design and Minimum Volume for Cleansing |
110037 |
Cosmetic,
Toiletry, and Fragrance Association |
Talc |
110038 |
Foster D.
Snell |
Pressure
Effects of Douching |
110039 |
Reed &
Carnrick Pharmaceuticals |
Douche Powders |
110042/43 |
Aloe Vera of |
Vagistat
Vaginal Douche |
110044 |
U.S. Borax
Research Corporation |
Boric
Acid/Sodium Borate |
110045 |
Proprietary
Association |
OTC Labeling
Indications |
110046/48 |
GAF
Corporation |
Povidone-Iodine |
110051 |
Purdue
Frederick Company |
Betadine
Douche |
110054 |
GAF
Corporation |
Povidone-Iodine |
110055 |
Proprietary
Association |
Comments on
Panel’s November 1978 Tentative Findings - “Information Copy” |
110057 |
GAF Corporation |
Povidone-Iodine |
110065 |
|
Cited
References (A - D) |
110066 |
|
Cited
References (E - J) |
110067 |
|
Cited
References (K - P) |
110068 |
|
Cited
References (Q - T) |
110069 |
|
Cited
References (U - Z) |
110070 |
|
Uncited
References |
llBPAI |
|
Panel
Administrator’s File (1.1 -
1.5) |
llBPAII(See
llAPA2) |
|
Panel
Administrator’s File (Minutes of Panel Meetings) |
llBPAIII |
|
Panel
Administrator’s File (Correspondence 1973 - 1975) |
llBPAIV |
|
Panel
Administrator’s File (Correspondence 1976 - 1977) |
llBPAV |
|
Panel
Administrator’s File (Correspondence 1978 - 1979) |
HEMORRHOIDAL (ANORECTAL) PANEL INDEX (12)
VOLUME |
SUBMITTED BY |
SUBJECT |
120001 |
Upjohn |
Tanicaine
Rectal Ointment and Suppositories |
120002 |
Upjohn |
Epinephricaine |
120003 |
Astra |
Xylocaine 2.5%
& 5% Ointment |
120004 |
Warner-Chilcott |
Anusol
Suppositories and Ointment |
120005 |
Resinol
Chemical Company |
Resinol
Greaseless Cream |
120006 |
Wyeth Labs |
Wyanoids
Suppositories Wyanoid Ointment Protegel |
120007 |
|
Preparation H
Ointment and Suppositories Volume I |
120008 |
|
Preparation H
Ointment and Suppositories Volume II |
120009 |
|
Preparation H
Ointment and Suppositories Volume III |
120010 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories Volume I |
120011 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories Volume II |
120012 |
Chesebrough-Pond’s |
Vaseline |
120013 |
Sterling Drug |
Pontocaine
Cream and Ointment Volume I |
120014 |
Sterling Drug |
PNS
Suppositories Volume II |
120015 |
Abbott |
Tronothane |
120016 |
Combe |
Lanacane Creme |
120017 |
Quist Chemical
Phenex |
Quist Ointment Phenex Rectal
Suppositories |
120018 |
Combe |
Lanacane Creme |
120019 |
Fuller |
Tucks |
120020 |
Pfizer |
Benzyl Alcohol |
120021 |
|
Live Yeast
Cell Derivative |
120022 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120023 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120024 |
Sterling Drug |
PNS
Suppositories |
120025 |
Merrell-National |
Diothane
Ointment |
120026 |
Sterling Drug |
Tyloxapol |
120027 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120028 |
Sterling Drug |
PNS
Suppositories |
120029 |
Dow Chemical |
Dyclone Creme |
120030 |
Dr. Kade Pharmazeutische |
Posterisan |
120031 |
Bristol-Myers |
Pazo Ointment
and Suppositories |
120032 |
|
Skin
Respiratory Factor |
120033 |
Fuller |
Tucks |
120034 |
Humphreys |
Hamamelis
Water |
120035 |
Bristol-Myers |
Medicated Anal
Wipe Foam |
120036 |
Dr. Kade Pharmazeutische |
Posterisan |
120037 |
Bristol-Myers |
Aerosol
Medicated Anal Wipe Foam |
120038 |
Combe |
Resorcinol |
120039 |
Reed &
Carnrick |
Non-Steroid
Proctofoam |
120040 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120041 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120042 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120043 |
Phenex |
Phenex |
120044 |
Combe |
Resorcinol |
120045 |
Bristol-Myers |
Combination
Policy Remarks |
120046 |
Philips-Roxane |
Gentz Wipes |
120047 |
Combe |
Lanacane Creme |
120048 |
Combe |
Resorcinol |
120049 |
Combe |
Resorcinol |
120050 |
Reed &
Carnrick |
Non-Steroid
Proctofoam |
120051 |
Various
Sources |
Unpublished
References |
120052 |
Chesebrough-Pond’s
|
Vaseline |
120053 |
Pharmaceutical |
Hemozone |
120054 |
University of |
Camphor |
120055 |
Astra |
Xylocaine
Ointment |
120056 |
Proprietary
Association |
Criteria For
Placing Category III Ingredients in Category I |
120057 |
Schwarting |
Lappa/Leptandra
Collinsonia |
120058 |
Proprietary Association |
Combination
Policy Statement |
120059 |
Dow Chemical |
Dyclone Creme
1% |
120060 |
|
Skin
Respiratory Factor |
120061 |
Dr. Trunkey |
Donor Site
Wound Study |
120062 |
American Home
Products |
Skin
Respiratory Factor |
120063 |
Chesebrough-Pond’s |
Vaseline |
120064 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120065 |
Reed &
Carnrick |
Non-Steroid
Proctofoam |
120066 |
Warner-Chilcott |
Anusol
Suppositories |
120067 |
Malmstrom
Chemicals |
Lanolin and
its Derivatives |
120068 |
Merrell-National |
Diothane
Ointment |
120069 |
American Home
Products |
Skin
Respiratory Factor |
120070 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120071 |
Ciba- Geigy |
Nupercainal
Ointment Protocol |
120072 |
Arnar-Stone |
Benzocaine |
120073 |
Merrell-National |
Diothane
Ointment/NDA 1-941 |
120074 |
Proprietary
Association |
Combination
& Testing Policies Comments |
120075 |
Merrell-National |
Diothane
Ointment |
120076 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120077 |
Ciba-Geigy |
Nupercainal
Ointment and Suppositories |
120078 |
Ciba-Geigy |
Nupercainal
Ointment |
120079 |
|
Allantoin
& Alcloxa |
120080 |
Proprietary
Association |
Comments on
Panel’s Draft Report Released December 1977 |
120081 |
Ciba-Geigy |
Nupercainal
Suppositories |
120082 |
|
Skin
Respiratory Factor |
120083 |
|
Miscellaneous
Hemorrhoidal Product Labeling |
120084 |
Abbott |
Tronothane
Cream & Jelly |
120085 |
Merrell-National |
Diothane
Ointment Volume I |
120086 |
Merrell-National |
Diothane
Ointment Volume II |
120087 |
Proprietary
Association |
Combination
& Testing Policies (Same as
Volume 120074) |
120088 |
Astro-Solar |
Tengum |
120089 |
|
Nupercainal
Ointment and Suppositories |
120090 |
Ciba-Geigy |
Transcript of
5/3/75 Meeting |
120091 |
Chesebrough-Pond’s |
Corrections of
Summary Minutes of 27th Meeting of Hemorrhoidal Panel |
120092 |
|
Skin
Respiratory Factor Presentation |
120093 |
|
Skin
Respiratory Factor
Presentation (References) |
Alphabetical Listing of
REFERENCES
CITED in Report
VOLUME |
|
120094 |
A |
120095 |
B |
120096 |
C |
120097 |
D-F |
120098 |
G-J |
120099 |
K-N |
120100 |
O-R |
120101 |
S |
120102 |
T-Z |
Alphabetical Listing of
REFERENCES
NOT CITED in Report
VOLUME |
CONTENTS |
120103 |
A-B |
120104 |
C-D |
120105 |
E-G |
120106 |
H-K |
120107 |
L-O |
120108 |
P-Z |
ADMINISTRATIVE FILE
OTC
ANORECTAL DRUG PRODUCTS
DOCKET NO. 80N-0050
VOLUME |
CONTENTS |
12APA1 |
Panel
Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Memebers and Liaisons 1.3 Curriculum Vitae of Panel Members and
Liaisons 1.4 General and Specific Charges to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and
Environmental Assessment Report |
12APA2 |
Panel
Administrator’s File, Volume II - Minutes of Panel Meetings. |
12APA3 |
Panel
Administrator’s File, Volume III - Correspondence File (1972-1980) |
Public Administrative File
OTC
Oral Health Care Drug Products
(Docket
No. 81N-0033)
VOLUME |
SUBMITTED BY |
|
130001 |
Monsanto |
Methyl
Salicylate |
130002 |
Henry Thayer
Co. |
Thayers
Slippery Elm Throat
lozenges |
130003 |
Lorvic Corp. |
Odara Solution |
130004 |
Hoyt |
Orabase with
Benzocaine |
130005 |
Cox Drugs |
Formula “U” |
130006 |
Manufacturing |
Pain-A-Lay |
130007 |
Merrell-National
Laboratories |
Cepacol
Mouthwash/Gargle |
130008 |
Merrell-National
Laboratories |
Cepacol Throat
Lozenges |
130009 130010 130011 |
Merrell-National
Laboratories |
Cepacol
Anesthetic Troches |
130012 |
Endo
laboratories, Inc. |
Benocol |
130013 |
Upjohn |
Oral
Pentacresol |
130014 |
Endo Laboratories,
Inc. |
Lidocol |
130015 |
Rystan Co.,
Inc. |
Chloresium |
130016 130017 |
International
Pharmaceutical Corp. |
Gly-oxide
Liquid |
130018 |
Endo
Laboratories, Inc. |
Dyclocol |
130019 130020 130021 130022 130023 130024 |
Richardson-Merrell,
Inc. |
Vicks
Medi-Trating Lozenges Vicks Oracin
Throat Lozenges |
130025 |
Church and
Dwight Co., Inc. |
Arm and Hammer
Baking Soda |
130026 |
K.I.K. |
Cheramist |
130027 130028 130029 |
Calgon
Consumer Products Co., Inc. |
Sucrets Cough
Control Lozenge |
130030 130031 |
Calgon
Consumer Products Co., Inc. |
Sucrets Sore
Throat Lozenge |
130032 130033 130034 130035 130036 |
Calgon
Consumer Products Co., Inc. |
Sucrets Cold
Decongestant |
130037 |
Block Drug
Co., Inc. |
Proxigel |
130038 130039 130040 |
Block Drug
Co., Inc. |
Chloraseptic |
130041 |
Warren-Teed |
Di-O-Chrome |
130042 130043 130044 130045 130046 130047 |
Warner-Lambert
Co. |
Listerine
Antiseptic |
130048 |
Cooper
Laboratories, Inc. |
Amosan |
130049 130050 |
Ciba-Geigy
Corp. |
Domiphen
Bromide |
130051 |
Ayerst
laboratories |
Larylgan
Throat Spray |
130052 |
Julius Schmid,
Inc. |
Comments |
130053 130054 130055 |
Johnson and
Johnson |
Micrin Plus
Gargle and Rinse |
130056 |
Purdue
Frederick Co. |
Betadine |
130057 |
Blair
Laboratories, Inc. |
Isodine
Concentrate |
130058 |
E.R. Squibb
and Sons, Inc. |
Spec-T
Decongestant Lozenges Spec-T Cough
Suppressant Spec-T
Anesthetic Lozenges Spec-T Throat
Spray |
130059 |
Block Drug
Co., Inc. |
Anesthetic,
Aqueous and Concentrate Mouthwash, and Aerosol Spray |
130060 |
Scott
Laboratories, Inc. |
Scott’s
Certified Peroxide of Hydrogen |
130061 130062 |
Merrell-National
Laboratories |
Anesthetic
Gargle/Rinse/Spray |
130063 130064 130065 |
Block Drug
Co., Inc. |
Chloraseptic |
130066 |
International
Pharmaceutical Corp. |
Gly-oxide
Liquid |
130067 130068 130069 |
Merrell-National
Laboratories |
Cepacol
Mouthwash/Gargle Cepacol
Lozenges Cepacol Troches Cepacol Discs |
130070 |
E.R. Squibb
and Sons, Inc. |
Spec-T Sore
Throat/Decongestant Lozenge Spec-T Sore
Throat/Cough Suppressant Lozenge Spec-T Sore
Throat/Anesthetic Lozenge |
130071 |
Cooper
Laboratories, Inc. |
Amosan |
130072 |
Schmidt
Laboratories |
Comments |
130073 |
McKesson
Laboratories |
Isodettes
Throat Lozenges |
130074 |
Warner-Lambert
Co. |
Listerine
Throat Lozenges |
130075 |
Hynson,
Westcott, and Dunning, Inc. |
Thantis
Lozenges |
130076 |
LaWall and
Harrison Research laboratories, Inc. |
Troutman’s
Cough Syrup |
130077 |
Reed and
Carnrick Pharmaceuticals |
Anesthetic
Mouthwash |
130078 |
Procter and
Gamble Co. |
Scope
Mouthwash and Gargle |
130079 130080 |
Calgon
Consumer Products Co., Inc. |
Sucrets Sore
Throat Lozenges |
130081 |
Reed and
Carnrick Pharmaceuticals |
Anesthetic
Mouthwash |
130082 |
|
Anbesol |
130083 |
Reed and
Carnrick Pharmaceuticals |
Benzocaine
Spray |
130084 |
International
Pharmaceutical Corp. |
Gly-oxide
Liquid |
130085 |
Cooper
Laboratories, Inc. |
Oral-B
Antiseptic Drops |
130086 |
The
Proprietary Association |
Journal of
Periodontal Research, Supplement No. 14, 1975 |
130087 |
Sterling Drug,
Inc. |
Campho-Phenique
Liquid Campho-Phenique
Powder |
130088 |
Ryatan Co.,
Inc. |
Choresium -
Data Supplement to
Volume 130015 |
130089 130090 |
Merrell-National
Laboratories |
Cepacol -
Addendum to Volume 130007 |
130091 |
Bernard L.
Oser Associates, Inc. |
Statement Data
to Volume 130042 |
130092 |
Warner-Lambert
Co. |
Supplemental
Data to Volume 130042 |
130093 |
Cooper
Laboratories, Inc.. |
Supplemental
Dat - “Actions of Oxygenating Agents on Oral Inflamations” |
130094 |
Cooper
Laboratories, Inc. |
Supplement to
Volume 130085 - Oral-B Antiseptic Drops |
130095 |
Richardson-Merrell,
Onc. |
Vicks Throat
Lozengers - Supplement to Volume 130019 |
130096 |
Warner-Lambert
Co. |
Supplemental
Data to Volume 130042 |
130097 |
Panelist Martin J.
Goldberg, D.D.S. |
Three Papers
from V. Periodontology, Volumes 45-46 |
130098 |
Cooper
Laboratories, Inc. |
Amosan -
Upadate of Data and Information to Volumes 130048, 130071, 130085, and 130093 |
130099 |
Industry
Liaison Joseph D.
Ambrozaitis, D.D.S., Ph. D. |
Bibliography:
“A Review of mal Odor” |
130100 130101 |
Sterling Drug,
Inc. |
Campho-Phenique
- Addendum to Volume 130087. |
130102 |
Colgate-Palmolive
Co. |
Benzethonium
Chloride Mouthrinse |
130103 |
The
Proprietary Association |
Letter of June
26, 1976 and Position Paper - Rationale for Establishing Antiseptic Activity
Mouthrinses |
130104 |
Plough, Inc. |
Aspergum |
130105 |
Sterling Drug,
Inc. |
Campho-
Phenique - Supplement to Volume 130087 |
130106 |
Richardson-Merrell,
Inc. |
Cepacol
Professional labeling for Mouthwash Gargle, Throat Lozenges, Anesthetic
Troches |
130107 |
Warner-Lambert
Co. |
Listerine -
Supplement to Volume 130042 |
130108 |
The
Proprietary Association |
Letter on
Mouth-odors |
130109 |
American
Association of Poison Control Centers |
Letter on
Camphor |
130110-A |
The Proprietary
Association |
Statement on
Combining Multiple Ingredients |
130110-B |
The
Proprietary Association |
Statement on
the Evaluation of Mouthrinses |
130111 |
Cooper
Laboratories, Inc. |
Amosan -
Supplemental Information to Volumes 130048, 130071, 130085 and 130093 |
130112 |
BASF Wyandotte
Corp. |
Pluronic
Polyols - Toxicity and irritation Data |
130113 |
Richardson-Merrell,
Inc. |
Metholated
Cough Drops - Updating Information to Volume 130019 |
130114 |
Richardson-Merrell,
Inc. |
Letter
Relevant to the Panel’s In-vitro Guidelines for an Antiseptic/Antimicrobial
Mouthwash |
130115 |
Colgate-Palmolive
Co. |
Benzethonium
Chloride - Supplemental Data to Volume 130102 |
130116 |
Richardson-Merrell,
Inc. |
Oracin Throat
Lozenges - Supplemental Data to Volume 130020 |
130117 |
The
Proprietary Association |
OTC Oral
Topical Antiseptics |
130118 |
Procter and
Gamble Co. |
Addendum to
Volume 130078 - Additional Data |
130119 |
The
Proprietary Association |
OTC
Combinations |
130120 |
Colgate-Palmolive
Co. |
Benzethonium
Chloride - Supplemental Data to Volume 130102 |
130121 |
Warner-Lambert
Co. |
Addendum to
Volume 130042 |
130122 |
Richardson-Merrell,
Inc. |
Cepacol
Concentrate - Labels for Dental Decanter and Gallon Bottle |
130123 |
Cooper
Laboratories, Inc. |
Oral B
Antiseptic Drops - Supplemental Information to Volume 130048 |
130124 |
Richardson-Merrell,
Inc. |
Menthol -
Additional Data to Volume 130019 |
130125 |
Warner-Lambert
Co. |
Listerine -
Additional Data to Volume 130042 |
130126 |
Warner-Lambert
Co. |
Listerine -
Additional Data to Volume 130042 |
130127 |
Beecham
Products |
Dyclonine Lozenges |
130128 |
Beecham
Products |
Dyclonine
Lozenges |
130129 |
Beecham
Products |
Dyclonine
Lozenges |
130130-A |
Beecham
Products |
Dyclonine
Lozenges |
130130-B |
Beecham
Products |
Dyclonine
Lozenges |
130131 |
|
Chloraseptic
Products - Additional Data to Volume 130038 |
130132 |
The
Proprietary Association |
The
Effectiveness of Locally Applied Topical Anesthetics |
130133 |
The
Proprietary Association |
Guidelines for
the Evaluation of Mouthwashes for the Reduction of Intrinsic Oral Malodor |
130134 |
Procter and Gamble
Co. |
Cetylpyridinium
Chloride and Domiphen Bromide Data |
130135 |
Warner-Lambert
Co. |
Listerine
Antiseptic |
130136 |
Warner-Lambert
Co. |
Listerine
Antiseptic |
130137 |
Warner-Lambert
Co. |
Listerine
Antiseptic |
130138 |
Merrell-National
Laboratories |
Cepacol Mouthwash/Gargle |
130139 |
Cooper
Laboratories, Inc. |
Amosan |
130140 |
Warner-Lambert
Co. |
Listerine
Antiseptic - Volatile Oils/Topical |
130141 |
The
Proprietary Association |
In-vitro
Evaluation of Antimicrobial Mouthrinses |
130142 |
The
Proprietary Association |
In-vitro Evaluation
of Antimicrobial Mouthrinses - Volumes 1,2, and 3 - Comments to the panel’s
Draft Report |
130143 |
Beecham
Products |
Sore throat
Product Labeling |
130144 |
Lever Brothers
Co. |
In-vitro
Antimicrobial Testing Guidelines |
130145 |
Oral Products
Hedonics |
“Bad Breath” |
130146 |
Richardson-Merrell,
Inc. |
Oracin Throat Lozenges |
130147 |
Ralph B.
D’Agostino |
Statistical
Evaluation of Studies on Cepacol and Scope |
130148 |
Ralph B.
D’Agostino |
Statistical
Analysis of Listerine Antiseptic |
130149 |
Division of
Medical Sciences, National Research Council/National |
Drug Efficacy
Study |
130150 |
Merrell-National
Laboratories |
Effects of
Local Anesthetics on Tactile Sensitivity Thresholds for Cutaneous and Mucous
Membranes |
130151 |
Merrell-National
Laboratories |
Cetylpyridinium
Chloride/Sodium Fluoride Solution |
130152 |
Cooper
Laboratories, Inc. |
Amosan |
130153 |
|
Guidelines for
Testing the Effectiveness of Locally Applied Topical Antiseptics Other Than
Mouthrinses |
130154 |
Hynson,
Wescott, and Dunning, Inc. |
Thantis
Lozenges (was 170040) |
130155 |
Panelist Arthur N.
Bahn, Ph.D. |
The Efficacy
of Mouthwashes |
130156 |
Warner-Lambert
Co. |
Listerine |
130157 |
Cooper
Laboratories, Inc. |
Amosan |
130158 |
Cooper
Laboratories, Inc. |
Amosan |
130159 |
Cooper
Laboratories, Inc. |
“Absorption of
Boron after Mouthwash Treatment with Bocosept” |
130160 |
Procter and
Gamble Co. |
Active
Ingedients in Scope - Cetylpyridinium Chloride and Domiphen Bromide |
130161 |
Procter and
Gamble Co. |
Information
Provided to Dr. D’Agostino for Statistical Evaluation |
130162 |
The
Proprietary Association |
Information
Pertaining to a Presentation by the Proprietary Association to the Panel |
130163 |
The
Proprietary Association |
Effectiveness
of Locally Applied Topical Antiseptics |
130164 |
Warner-Lambert
Co. |
Listerine
Antiseptic - Drug vs Cosmetic Claims/Comment on Draft Report |
130165 |
Merrell-National
Laboratories |
Safety and
Effectiveness of Cetylpyridinium Chloride |
130166 |
Merrell-National
Laboratories |
Safety and
Effectiveness of Cetylpyridinium Chloride |
130167 |
Merrell-National
Laboratories |
Safety and
Effectiveness of Cetylpyridinium Chloride |
130168 |
Merrell-National
Laboratories |
Safety and
Effectiveness of Cetylpyridinium Chloride |
130169 |
Merrell-National
Laboratories |
Safety and
Effetiveness of Cetylpyridinium Chloride |
130170 |
Merrell-National
laboratories |
Safety and
Effectiveness of Cetylpyridinium Chloride |
130171 |
Merrell-National
Laboratories |
Safety and
Effectiveness of Cetylpyridinium Chloride |
130172 |
Warner-Lambert
Co. |
Relationship
between Plaque, Bacteria, and Oral Disease |
130173 |
Walter J.
Loesche, D.M.D., Ph. D |
In-vitro and
In-vivo Testing of Antiseptic Mouthrinses |
130174 |
Procter and
Gamble Co. |
Dental Plaque
- Gingivitis and Dental Caries |
130175 |
|
Methods for
Measuring Plaque |
130176 |
Purdue
Frederick Co. |
Povidone-Iodine |
130177 |
Whitehall
Laboratories, Inc. |
Anbesol |
130178 |
Louis P.
Gangerosa, Sr., D.D.S. |
Comments |
130179 |
Warner-Lambert
Co. |
Listerine |
130180 |
Plough, Inc. |
Topical
Analgesics (Asprin) and Sore Throat |
130181 |
Nathaniel H.
Rowe, D.D.S. |
Comments -
Dental Plaque |
130182 |
The
Proprietary Association |
Soft Tissue
Responses to High Frequency Use of Experimental and Commercial Mouthwashes |
130183 |
Purdue
Frederick Co. |
Providone-Iodine
- Testing |
130184 |
Panelist Arthur N.
Bahn, Ph. D. |
Minority
Report, OTC advisory Panel on OTC oral Cavity Drug Products |
130185 |
Irwin D.
Mandel, D.D.S. |
Plaque and
Dental Disease |
130186 |
Cooper
Laboratories, Inc. |
Amosan |
130187 |
Procter and
Gamble Co. |
Domiphen
Bromide Alone and in Combination with Cetylpyridinium Chloride |
130188 |
The
Proprietary association |
Comments on
the Information Copy of the panel’s Report |
130189 |
Panelist Walter E.
Loch, M.D. |
Comments on
Monograph |
130190 |
The
Proprietary Association |
Comments on
“Methods of Expressing Strength of Drugs” |
130191 |
University
Faculty Members |
Comments on
Plague, Gingivitis, or Microbial Activity in the Mouth as Related to OTC
Mouthwashes |
130192 |
Panel Chairman
Lawrences Cohen, Ph. D., M.D., D.D.S. |
Statement to
the OTC Panel |
130193 |
D. B. Smith,
D.D.S. |
Clarification
of Data in his Paper on Mouthwashs and Oral Cancer |
Public Administrative File
OTC
Oral Health Care Drug Products
(Docket
No. 81N-0033)
Alphabetical
Listing of
References
Cited in the Report
VOLUME |
|
130194 |
A |
130195 |
B |
130196 |
C |
130197 |
D-E |
130198 |
F-G |
130199 |
H-J |
130200 |
K-L |
130201 |
M-N |
130202 |
O-R |
130203 |
S |
130204 |
T-Z |
130205 |
Miscellaneous
Uncited References A-G |
130206 |
Miscellaneous
Uncited references H-Z |
Public Administrative File
OTC
Oral Health Care Drug Products
(Docket
No. 81N-0033)
Panel
Administrator’s File
VOLUME |
|
130PA1 |
Panel
Administrator’s File Volume I -
General 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Memebrs
and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions |
130PA2 |
Panel
Administrator’s File, Volume II -
Minutes of Panel Meetings |
130PA3 |
Panel
Administrator’s File, Volume III -
Correspondence File (1973-1982). |
File July
7, 1975
Panel
Administrator
OTC
Division
Zirconium
Report 75N-0003
The
following volumes of data were hand-carried to Room 14-65 this date:
VOLUME |
|
140032 |
Carter-Wallace |
140034 |
Carter-Wallace |
140035 |
Gillette -
Right Guard Extra Strength |
140036 |
|
140037 |
Proctor &
Gamble - Secret, Sure |
140038 |
Proctor &
Gamble |
140039 |
Proctor &
Gamble |
140042 |
Proctor &
Gamble |
140043 |
Proctor &
Gamble |
140046 |
Proctor &
Gamble |
140048 |
Proctor &
Gamble |
140049 |
Carter-Wallace
- Arrid XX |
140050 |
Gillette |
140000 |
A -
Correspondence File B - Summary
Minutes - Antiperspirant Panel C- References |
Docket
Number 75N-0003 has been assigned by the Hearing Clerk for the Zirconium
Report.
Lee
Geismar
ANTIPERSPIRANT
OTC DRUGS
DATA
AND INFORMATION
SUBMITTED BY |
TRADE NAME |
INGEDIENTS AND CONCENTRATION |
|
140001-3 |
Gillette |
Right Guard
Antiperspirant |
3.4% Al
Chlorhydroxide |
140004 |
Gillette |
Right Guard
natural Scent Antiperspirant |
3.4% Al
Chlorhydroxide |
140005 |
Gillette |
Right Guard
Powder Dry Antiperspirant |
3.4% Al
Chlorhydroxide |
140006 |
Gillette |
Soft & Dri
Lightly Powdered Antiperspirant Deodorant |
3.4% Al
Chlorhydroxide |
140007 |
Gillette |
Soft & Dri
Unscented Antiperspirant |
3.4 Al
Chlorhydroxide |
140008 |
Gillette |
Soft & Dri
Scented Antiperspirant |
3.4 Al
Chlorhydroxide |
140009 |
Gillette |
X-Hydra
Antiperspirant Deodorant Liquid |
20% Active Al
Chlorhydroxide 3.6% Al
Chloride 5% Cetyl
Alcohol |
140010 |
Gillette |
X-Hydra
Antiperspirant Deodorant Liquid |
15% Active Al
Chlorhydroxide 7.2% Aluminum
Chloride 44% Alcohol |
140011 |
Armour-Dial |
Dial
Antiperspirant Aerosol |
3.5% Al
Chlorhydroxide |
140012 |
Red Foot |
Redfoot |
8-Hydroxyquinoline
sulfate 0.75%,
Aluminum Potassium Sulfate 1.5%,
Salicylic Acid 20%, Boric Acid
10%, Magnesium Stearate |
140013 |
Aerosol
Techniques Aerosol
Techniques Aerosol
Techniques |
Antiperspirant
Spray Extra Dry Super Dri-Mist
Heavy Duty
Antiperspirant Rite-Aid Extra
Dry Antiperspirant
Spray |
3.5% or 4.0%
Al Chlorhydroxide Aluminum
Chlorhydroxide 5.5% Al Chlorhydroxide
complex Al
Chlorhydroxide 4.20% |
140014 |
Reheis Reheis Reheis Reheis Reheis Reheis Reheis Reheis |
Chlorhydrol
Powder Chlorhydrol
Solution Micro-Dry
Ultrafine Micro-Dry
Ultrafine Basic Aluminum
Bromide Rehydrol Chloracel
Solid Chloracel
Solution |
Al
Chlorhydroxide Complex Al
Chlorhydroxide complex 50% Al
Chlorhydrate impalpable Al
Chlorhydrate impalpable Basic Aluminum
Bromide Al
Chlorhydroxide-Propylene Glycol Complex Sodium
Aluminum Chlorhydroxy Lactate Sodium Aluminum
Chlorhydroxy Lactate 40% |
140015 |
Armour-Dial Armour-Dial |
Dial
Antiperspirant Roll-On
(Scented) Dial
Antiperspirant Roll-On
(Unscented) |
Al
Chlorhydroxide 20% Al
Chlorhydroxide 20% |
140016 |
Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug |
Body All
Powdery Spray Deodorant and
Antiperspirant Dorothy Gray
Antiperspirant Atomist Deodorant Dorothy Gray
Spin Roll-On Deodoorant Antiperspirant Givenchy
Gentleman Antiperspirant Deodorant Spray Tussy Dry
Antiperspirant Spray Tussy Roll-On
Deodorant Tussy Roll-On
Deodorant Extra Strength Tussy Roll-On
Deodorant (Unscented) |
Al
Chlorhydrate 3% Al
Chlorhydroxide 2% Alcohol 61% Al
chlorhydroxide complex 20% Alcohol 25.17% Al Chlorhydrate
3% Al
Chlorhydrate Compound 3.36% Al
Chlorhydrate 19.85% Al
Chlorhydroxide 24% Al
Chlorhydroxide 19.85% |
140017 |
Sterling Drug Sterling Drug Sterling Drug Sterling Drug |
Dorothy Gray
Antiperspirant Cream Tussy Cream
Deodorant Tussy Extra Strength
Cream Deodorant Tussy
Unscented Cream Deodorant |
Aluminum
Sulfate 8.74% Aluminum
Sulfate 8.74% Aluminum
Sulfate 10.27% Aluminum
Sulfate 8.74% |
140018 |
Carter
Products Carter
Products |
Arrid Cream Arrid Cream
with Chlorophyll |
Aluminum
chlorhydrate 21.25% Aluminum
chlorhydrate 21.25% Aluminum
Chloride 1% |
140019 |
Carter
Products |
Arrid
Antiperspirant Roll-On
Deodorant |
Aluminum
Sulfate 8% Sodium
Aluminum Lactate 8% Water Soluble
Lanolin |
140020 |
Carter
Products Carter
Products |
Light Powder
Arrid Extra Dry
Antiperspirant Spray Light Powder
Arrid Extra Dry Unscented Antiperspirant Spray |
Aluminum
chlordrate 3.5% Aluminum
Chlorhydrate 3.5% |
140021 |
|
Allercreme
Aerosol Antiperspirant
Deodorant Allercreme
Aerosol Antiperspirant Deodorant (Unscented) Allercreme
Antiperspirant Deodorant Creme Allercreme
Antiperspirant Deodorant Creme (Unscented) Allercreme
Liquid Spray Antiperspirant Deodorant Allercreme
Liquid Spray Antiperspirant Deodorant (Unscented) Allercreme
Roll-On Antiperspirant Deodorant Allercreme
Roll-On Antiperspirant Deodorant (Unscented) Maxi-Dry
Hypo-Allergenic Antiperspirant Roll-On Maxi-Dry
Hypo-Allergenic Antiperspirant Roll-On (Unscented) Maxi-Dry
Hypo-Allergenic Antiperspirant Cream Maxi-Dry
Hypo-Allergenic Antiperspirant Cream (Unscented) |
Aluminum chlorhydroxide
20% Aluminum
Chlorhydroxide 20% Aluminum
Chlorhydroxide 20% Aluminum
Chlorhydroxide 20% Aluminum
Chlorhydroxide 20% Alcohol 58% Aluminum
Chlorhydroxide 20% Aluminum
Chlorhydroxide 20% Aluminum
Chlorhydroxide 20% Aluminum
Chlorhydroxide 25% Aluminum
Chlorhydroxide 25% Aluminum
Chlorhydroxide 25% Aluminum
Chlorhydroxide 25% |
140022 |
Carter
Products |
|
Zinc
Phenolsulfonate |
140023 |
USV
Pharmaceutical USV
Pharmaceutical USV
Pharmaceutical USV
Pharmaceutical USV
Pharmaceutical USV
Pharmaceutical USV
Pharmaceutical USV
Pharmaceutical |
Mitchum
Antiperspirant Spray Mitchum
Antiperspirant Spray (Unscented) Mitchum
Antiperspirant Spray Powder Mitchum
Antiperspirant Spray Powder (Unscented) Mitchum Cream
Antiperspirant Mitchum
Antiperspirant Scented Liquid Mitchum
Antiperspirant Unscented Liquid Mitchum
Antiperspirant Stick |
Aluminum
Hydroxychloride 2.8% Aluminum
Chloride 1.4% Aluminum
Hydroxychloride 2.8% Aluminum
Chloride 1.4% Aluminum
Hydroxychloride 3.5% Aluminum
Hydroxychloride 3.5% Aluminum
Chlorhydrol 19% Aluminum
Chloride 4% Aluminum
Chlorhydrol 14% Aluminum
Chloride 7.3% Aluminum
Chlorhydrol 14.98% Aluminum
Chloride 7.79% Aluminum
Chlorhydrol 14% Aluminum
Chloride 7% |
140024-29 |
Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers |
Ammens Foot
Powder Ban Roll-On Antiperspirant Deodorant Unscented Ban
Roll-On Antiperspirant Deodorant Ban
Antiperspirant Cream Deodorant Ban Deodorant
Spray Dry Ban
Antiperspirnt Deodorant Spray The Dry System
Antiperspirant Cream The Dry System
Antiperspirant Lotion Concentrate Mum Cream
Deodorant Mum Roll-On
Deodorant Mum Spray
Deodorant Mum Powder
Spray Antiperspirant Deodorant Softalc
Deodorant Spray Powder Softalc
Deodorant Spray Powder (Unscented) Trig
Antiperspirant Roll-On Deodorant Trig Antiperspirant
Roll-On Deodorant (Unscented) |
Aluminum
Chlorhydrate 2% Aluminum
Chlorhydrate 22% Aluminum
Chlorhydrate Aluminum
chlorhydroxide 18.4% Aluminum
Chloride 3.6% Aluminum
chlorhydrate 1.875% Ethyl Alcohol
53% Aluminum
chlorhydrate 3.75% Aluminum chloride
4.5% Aluminum
chlorhydroxide 23% Aluminum
Chloride 3.6% Aluminum
Chlorhydroxide 20.4% Aluminum
Chlorhydrate 10% Aluminum
Chlorhydrate 10% Aluminum
Chlordrate 1.875% Ethyl Alcohol
53% Aluminum
chlorhydrate 3.5% Aluminum
chlorhydrate 2% Aluminum
chlohydrate 2% Aluminum
chlorhydroxide 22% Aluminum
Chlorhydroxide 22% |
140024-29 |
Bristol-Myers Bristol-Myers Bristol-Myers |
Ultra Ban 5000
Antiperspirant Ultra Ban 5000 Antiperspirant
(Unscented) Ultra Ban
Powder Spray |
Aluminum
chlorhydrate 4.04% Aluminum
Chloride 0.9% Aluminum
chlorhydrate 4.04% Aluminum
Chloride 0.9% Aluminum
chlorhydrate 3.5% |
140030-31 |
Carter
Products Carter
Products |
Arrid Extra
Dry Antiperspirant Spray Arrid Extra
Dry unscented Antiperspirant Spray |
Aluminum
chlorhydrate 3.5% Aluminum
chlorhydrate 3.5% |
140032 |
Carter
Products |
Antiperspirant
Spray (Experimental) |
Aluminum
Chlorohydrate 4% Zirconium
chlorohydrate 1% |
140033 |
Carter
Products |
Hour After
hour Antiperspirant |
Aluminum
chlorhydrate 3% |
140034 |
Carter Products |
|
Aluminum
Chlorohydrate Zirconium
chlorohydrate |
140035-36 |
Gillette |
Right Guard
Extra Strength Antiperspirant |
Aluminum
chlorhydrate, Zirconium oxychloride Aluminum glycinate |
140037-38 |
Proctor &
Gamble |
Secret 7 Sure
Antiperspirants |
Zirconium
chlorohydrate, Aluminum chlorhydrate Glycine complex |
140039 |
Proctor &
Gamble |
Additional
Data |
|
140040 |
FDA Document |
90-day
subacute aerosol inhalation toxicity study |
|
140041 |
Pennwalt Corp. |
Fresh Stick |
Sodium
Aluminum chlorhydroxylactate |
140042-43 |
Proctor &
Gamble |
Additional
Data |
|
140044-45 |
Leon Products,
Inc. |
Certain-dri |
Aluminum
Chloride 13.3% |
140046 |
Proctor &
Gamble |
Additional
Data |
|
140047 |
Leon Products,
Inc. |
Additional
Data |
|
140048 |
Proctor &
Gamble |
Additional
Data |
Zirconium-Aluminum-Glycine
Complex |
140049 |
Carter
Products Div., Carter-Wallace,
Inc. |
Arrid XX
Antiperspirant Spray |
Aluminum-Zirconium
Chlorohydrate Complex |
140051 |
Carter
Products |
Additional
Data on Arrid Extra Dry |
|
140052 |
Carter
Products |
Additional
Data on Arrid Roll-on |
|
140053 |
Avon Products,
Inc. |
Particle size
measurements in aerosolized talc |
|
140053A |
Wickhen
Products, Inc. |
Wickenol 303 Wickenol 321 Wickenol 323 Wickenol 324 Wickenol 340 Wickenol 363D |
Aluminum
Chlorhydrate-50% aqueous solution Aluminum
Chlorhydrate crystals Aluminum
Chlorhydrate Impalpaple powder Aluminum
Chlorhydrate low-moisture impalpaple powder Sodium
Aluminum Lactate powder Alcohol
Soluble Aluminum Chlohydrate powder |
140054 |
The Cosmetic,
Toiletry, & Fragrance Association, Inc. |
Additional
information on “Antiperspirant Testing Protocol” |
|
140055 |
Lehn &
Fink |
Body
All--Additional information |
|
140056 |
CTFA |
Additional
testing procedures |
|
140057 |
Person &
Covey, Inc. |
Drysol |
Aluminum
chloride 20% |
140058 |
Gillette
Medical Evaluation Laboratories |
Super Dri Soft
and Dri and Right Guard Double Protection Roll-on Antiperspirant |
20%
Aluminum-zirconyl-hydroxychloride complex |
140059 |
The Cosmetic,
Toiletry and Fragrance Assn., Inc. |
Information on
ingredient nomenclature |
|
140060 |
Person &
Covey, Inc. |
Drysol |
Additional Data |
140061 |
Carter
Products Gillette
Medical Evaluations Laboratories Sterling Drug,
Inc. Revlon
Research Center, Inc. Bristol-Myers
Proucts The Proctor
& Gamble Co. Reheis
Chemical Company CTFA Armour-Dial,
Inc. |
Nomenclature
for ingredients “ ” “ ” “ ” “ ” Nomenclature
for ingredients and usage and dosage levels Nomenclature Information on
water of hydration for ingredients Nomenclature |
|
140062 |
The Cosmetic,
Toiletry and Fragrance Assn., Inc. |
Safety of talc |
|
140063 |
Person and
Covey, inc. |
Drysol |
Additional
data |
140064 |
CTFA |
Safety
Protocol for aerosols |
|
140065 THRU
140068 |
REFERENCES
(Alphabetical by Author) PANEL
ADMINISTRATOR’S FILE VOLUME I Members C.V.’s Charge to
Panel Summary
Minutes Regulatory
Analysis Assessment Statement of
Exemption and Environmental Assessment Reports PANEL
ADMINISTRATOR’S FILE VOLUME II Correspondence |
TFM VOLUME 1400PR
Has been established for Antiperspirant
Drug
Products
Public
Administrative File
OTC
Vitamin and Mineral Drug Products
(Docket
No. 78N-0024)
SUBMITTED BY |
TRADE NAME/SUBJECT |
|
150001 |
Schering Corp. |
Mol-Iron
Liquid Mol-Iron
Tablets Mol-Iron
Chronosule Tablets |
150002 |
The Central
Pharmacal Co. |
Niferex
Tablets Niferex Elixir Niferex-150
Capsules |
150003 |
Marion
Laboratories, Inc. |
Os-Cal tablets |
150004 |
Mallinckrodt
Chemical Works |
Toleron
Suspension Toleron
Tablets |
150005 |
Eastman
Chemical Products, Inc. |
Vitamin E |
150006 |
Ross
laboratories |
Proposed
Products for Women on Oral Contraceptives |
150007 |
International
Pharmaceutical Corp. |
Calcident
Tablets |
150008 |
Smith Kline
& French Laboratories |
Feosol
Spansule Capsules |
150009- 150010 |
Cooper
laboratories, Inc. |
Ferronord
Tablets Vitron-C
Hematinic Tablets |
150011 |
Merrell-National
Laboratories |
Simron Plus
Capsules |
150012 |
Merrell-National
Laboratories |
Simron
Capsules |
150013 |
A.H. Robins
Co. |
Allbee-T
Mult-vitamins |
150014 |
A.H. Robins
Co. |
Adabee
Multivitamins Adabe with
Minerals Tables |
150015 |
A.H. Robins
Co. |
Allbee
Capsules Allbee w/C
Capsules |
150016 |
E.R. Squibb
& Sons, Inc. |
Theragran
Tablets Theragran
Liquid Theragran-M Tablets |
150017 |
E.R. Squibb
& Sons, Inc. |
Vitamin B-1
100mg Tablets Vitamin B-1
50mg Tablets |
150018 |
E.R. Squibb
& Sons, Inc. |
Iron with
Vitamin C Tablets |
150019 |
E.R. Squibb
& Sons, Inc. |
Vitamin B-12
Capsules |
150020 |
E.R. Squibb
& Sons, Inc. |
Niacin Tablets |
150021 |
E.R. Squibb
& Sons, Inc. |
Vitamin A from
Natural Sources Capsules Vitamin A
Capsules |
150022 |
E.R. Squibb
& Sons, Inc. |
B Complex with
Vitamin C Capsules Stress Formula
B Complex with Vitamin C Tablets |
150023 |
E.R. Squibb
& Sons, Inc. |
Vitamin C
Tablets Vitamin C Vitamin C
Tablets (Golden Bountry) |
150024 |
E.R. Squibb
& Sons, Inc. |
Vitamin E
Walnut Flavored Tablets Vitamin E
Capsules Natural
Vitamin E Capsules |
150025 |
Pfizer
Pharmaceuticals |
Crystalets Vitamin A
Palmilets Stablets |
150026- 150027 |
Hoffmann-LaRoche,
Inc. |
Vitamin A |
150028 |
Hoffmann-LaRoche,
Inc. |
Thiamine |
150029 |
Hoffmann-LaRoache,
Inc. |
Riboflavin |
150030 |
Hoffmann-LaRoache,
Inc. |
Niacin |
150031 |
Hoffmann-LaRoache,
Inc. |
Vitamin B-6 |
150032 |
Hoffmann-LaRoache,
Inc. |
Panthothenic
Acid |
150033- 150034 |
Hoffmann-LaRoache,
Inc. |
Ascorbic Acid |
150035 |
Hoffmann-LaRoache,
Inc. |
Vitamin E |
150036 |
Hoffmann-LaRoache,
Inc. |
Biotin |
150037 |
Lederle
Laboratories |
Filibon
Prenatal Capsules Filbon OT
Prenatal Tablets Gevrabon
Vitamin Mineral Supplement Gevral
Capsules Gevral T
Capsules Gevral Protein Gevrite
Tablets Lederplex
Capsules Lederplex
Liquid Lederplex
Tablets Stresscaps Stresstabs 600 Vi-Magna
Capsules Ferro-Mandets
Tablets Ferro-Sequels
Capsules Incremin with
Iron Syrup Peritinic
Tablets Recoup Tablets |
150038 |
William H.
Rorer, Inc. |
Fermalox
Tablets |
150039 |
Abbott
Laboratories |
Fero-Gradumet
Filmtab Fero-Grad-500
Filmtabs Iberet Filmtab
Tablets Iberet Liquid Iberet-500
Filmtab Tablet Iberet -500
Liquid Iberol Filmtab
Tablets Iberol-F
Filmtab Tablets Daylong
Tablets |
150040 |
Abbott
Laboratories |
Optilets-500
Filmtab Tablets Optilets-M-500
Filmtab Tablets Surbex Filmtab
Tablets Surbex w/C
Filmtab Tablets Surbex-T
Filmtab Tablets |
150041 |
ICI America
Inc. |
Ferancee
Hematinic Tablets Ferancee-HP
Hematinic Tablets Orexin
Therapeutic Vitamin Supplement Tablets Probec Tablets Probec-T
Tablets Theron Tablets Stuart
Therapeutic Multivitamin Tablets Stuart
Hematinic Liquid Stuart
Hematinic Tablets Mucoplex
Tablets Stuartinic
Hematinic Tablets |
150042 |
Plus Products |
Plus Formula
10 Multimineral Tablets Plus Formula
14 Multi-mins Tablets Plus Formula
15 Multi-mins Tablets Plus Formula
22 Magnesium Oxide Powder Plus Formula
23 Manganese Tablets Plus Formula
49 Vitamin B Complex Tablets Plus Formula
49A Vitamin B Complex Tablets Plus Formula
50 Liver, Iron & B Vitamins Tablets Plus Formula
70 Vitamin B Complex Tablets with Vitamin C Plus Formaula
71 High Potency Vitamin B Complex with Vitamin C Tablets Plus Formula
72 Stress Supplement Tablets Plus Formula
74 Vitamin & Mineral Supplement Perles Plus Formula
75 B Complex 75 Tablets Plus Formula
77 Vitamin B Complex Syrup with Iron Plus Formula
78 Vitamin Syrup for Children Plus Formula
80A Bone Meal Powder Plus Formula
85 Natural Bone Meal with Magnesium, Manganese & Zinc Tablets Plus Formula
92 Granular Soya Lecithin Plus Formula
93A Lecithin Perles Plus Formula
100 DFS Perles Plus Formula
101A Vitamin A Perles Plus Formula
104A Emulsified A Perles Plus Formula
123 Paraaminobenzoic Acid (PABA) Tablets Plus Formula 125A
Inositol Tablets Plus Formula
126 Inositol Powder Plus Formula
152 Emulsified Vitamin E Complex Perles Plus Formula
153 Vitamin E Complex Perles |
150042
cont.......... |
|
Plus Formula
154A Emulsified Vitamin E Complex Perles Plus Formula
155 Vitamin E Complex Perles Plus Formula
156 Vitamin E Complex Perles Plus Formula
158 Vitamin E Tablets Plus Formula
159 Vitamin E Perles Plus Formula
162 Vitamin E Perles Plus Formula
163 Vitamin E Perles Plus Formula
164 Vitamin E Perles Plus Formula
165 Vitamine E Perles Plus Formula
175 Dietary Food Supplement Perles Plus Formula
180 Potassium & Iodine Tablets Plus Formula
184 Calcium and Magnesium Tablets Plus Formula
202A Vitamins A & D Perles Plus Formula
203A Vitamins A & D Tablets Plus Formula
205A Vitamins A,D, 7 E Perles Plus Formula
206 A, D & E Drops Plus Formula
207 Vitamins A & Plus Formula
222 High Potency Cod Liver Oil Plus Formula
234 Vitamin B-1 Tablets Plus Formula
242 Vitamin B-2 Tablets Plus Formula
249 Dried Yeast Tablets Plus Formula
250 Yeast Plus Plus Formula
251 Vitamin B-6 Tablets Plus Formula
252 Vitamin B-6 Tablets Plus Formula
253 Vitamin B-6 Tablets Plus Formula
260 Niacin Tablets Plus Formula
263 Niacinamide Tablets Plus Formula
264A Pantothenic Acid Tablets Plus Formula 265A
Acerola Chews Tablets Plus Formula
266A Chewable Vitamin C Tablets |
150042
cont.... |
|
Plus Formula
267A Chewable Vitamin C Tablets Plus Formula
273A Vitamin C Tablets Plus Formula
275 Vitamin C Complex Plus Formula
277 Vitamin C Complex Plus Formula
278 Vitamin C Powder Plus Formula
279 Vitamin C Powder Plus Formula
280A Vitamin C Tablets Plus Formula
282 Vitamin C Complex Tablets Plus Formula
290 Granular Kelp Plus Formula
304 Vitamin B-12 Tablets Plus Formula
333 Dried Yeast and Iron Tablets Plus Formula
380 Mint-A-Mins Chewable Vitamin Wafers Plus Formula
450 Instant Brewer’s Yeast Plus Formula
445 Iron Supplement Tablets Plus Formula
740 Tiger’s Milk Cookies Plus Formula
745 Tiger’s Milk Carob Coated Bar Plus Formula
746 Tiger’s Milk Real Peanut Butter Bar Plus Formula
747 Tiger’s Milk Peanut Butter & Honey Bar Plus Formula
748 Tiger’s milk Peanut Butter & Jelly Bar Plus Formula
749 Tiger’s Milk Calorie Watcher’s Snack Plus Formula
800 Tiger’s Milk Nutrition Booster Plain Plus Formula
825 Tiger’s Milk Nutrition Booster Natural Carob Flavor Plus Formula
850 Tiger’s Milk Nutrition Booster Vanilla Flavor Plus Formula
875 Nutrition Booster Natural Plus Formula
86 Zinc 30mg Tablets Plus Formula
87 Zinc Tablets Plus Formula
98 Vita-Fems Tablets Plus Formula
122 PABA Tablets |
150042
cont............ |
|
Plus Formula
127 Choline Tablets Plus Formula
128 Inositol Tablets Plus Formula
157 Vitamin E Capsules Plus Formula
160 Vitamin E Capsules Plus Formula
166 Vitamin E Capsules Plus Formula
243 Vitamin B-2 Tablets Plus Formula
244 Vitamin B-2 Tablets Plus Formula
259 Pantothenic Acid Tablets Plus Formula
261 Niacin Tablets Plus formula
262 Niacinamide Tablets Plus Formula
303 Vitamin B-12 Tablets |
150043- 150047 |
The J.B.
Williams Company, Inc. |
Geritol Liquid Geritol
Tablets |
150048 |
Ross
Laboratories |
Alpha
Tocopheryl Polyethylene Glycol 1000 Succinate |
150049 |
Signet
Laboratories Incorporated |
B-12 Tablets Double
Absorption B-12 Tablets Vitamin B-6
Tablets Vitamin B-1
Tablets Vitamin B-2
Tablets Double
Absorption B-12 Tablets Anti-X Tablets pantothenic
Acid Tablets Citrex Plus
Tablets Toco E Sol
Tablets Taste-E-Tab Power-B w/PABA
Tablets Intensive Care
B with C Tablets Premium
Nutrition Plan Tablets Omni Nutrition
Plan Tablets One Plan
Multi-Vitamin-Mineral Supplement Tablets Ultra-Vite
Multi-Vitamin-Mineral Supplement Tablets Neo-Tone
Asimicaps Iron with
Vitamins & Minerals Tablets Mag-Cal
Balanced Super Citrex Tablets |
150050- 150052 |
McMurray &
Pendergast (For Vita-minerals, Inc.) |
Bioflavanoids |
150053 |
A.E. Staley
Manufacturing Co. |
Inositol |
150054 |
LaWall &
Harrison Research Laboratories, Inc. |
S.S.S. Tonic
Tablets |
150055 |
LaWall &
Harrison Research Laboratories, Inc. |
S.S.S. Tonic
(Liquid) |
150056 |
Mead Johnson
Laboratories |
Feminins
Tablets |
150057 |
Sterling Drug
Inc. |
Fergon
Capsules Fergon w/C
Caplets Fergon
Compound Elixir Fergon Elixir Fergon Tablets Ironized Yeast
Tablets |
150058 |
Sterling Drug
Inc. |
Afaxin
Capsules |
150059 |
Sterling Drug
Inc. |
Betaxin
Tablets |
150060 |
Sterling Drug
Inc. |
Drisdol |
150061 |
Sterling Drug
Inc. |
Pluravit
Capsules Pluraxin
Capsules |
150062 |
Wm. T.
Thompson Co. |
Zinc Tablets Trace Elements
Tablets Fluoride
Tablets Multi-Minerals
w/Sea Minerals Tablets |
150063 |
Wm. T.
Thompson Co. |
Vitamin A
Tablets Vitamin A
& Vitamin D Capsules Vitamin D
Tablets Vitamin E
Tablets Vitamin E
Capsules Vitamin E
& C with A Capsules Vitamin K-1
Tablets |
150064 |
Wm. T.
Thompson Co. |
Acerola C
Chewable Tablets Vitamin C
Tablets One Gram C
Capsules C Ross Hips
Tablets C-Flavoids
“500" Tablets Rose Hips C-Flavoids
“650" Tablets Flavoid
Complex Tablets |
150065 |
Wm. T.
Thompson Co. |
Ex-Po 36
Capsules (proposed) Ex-Po 36
Capsules Nuplex Tablets Iron Hematinic
Tablets Neo-Globin
Tablets |
150066 |
Wm. T.
Thompson Co. |
Vitamin B-1
Tablets Vitamin B-2
Tablets Vitamin B-6
Tablets Vitamin B-12
Tablets B Complex Plus
C Tablets B Complex
“50" Tablets (proposed) B-Complex
“50" Capsules B-Complex
Capsules (proposed) Niacin Tablets NiacinamideTablets Pantothenic
Acid Tablets Folic Acid
Tablets |
150067 |
Ayerst
Laboratories |
Beminal 500
Tablets Beminal Forte
with Vitamin C Capsules Beninal
Vitamin B Complex with Iron and Liver Capsules Cytoferin
Tablets Clusivol Chew
Tablets Clusivet
Tablets Clusivol Syrup |
150068- 150069 |
Vitaminerals,
Inc. |
Data and views
on Vitamin D |
150070- 150071 |
Vitaminerals,
Inc. |
Data and views
on Vitamin A |
150072 |
see 150126 |
|
150073 |
The Council
for Responsible Nutrition |
Example labels
of member companies. Safety and
Efficacy review for Vitamins A, C, E, Niacin and fat soluable vitamin
combinations-Data & Views |
150074 |
The Council
for Responsible Nutrition |
Vitamin A
reference bibliography. |
150075 |
The Council
for Responsible Nutrition |
Ascorbic
reference bibliography |
150076 |
The Council
for Responsible Nutrition |
Reference
bibliography for Vitamin E. |
150077 |
The Council
for Responsible Nutrition |
Reference
bibliography for Niacin and Niacinamide |
150078 |
The Council
for Responsible Nutrition |
Reference
bibliography for fat-soluble vitamins (A, E, D). |
150079 |
Radiance
Products Co. |
Super Potency
Multiple Vitamins & Minerals Tablets Norwegian Cod
Liver Oil w/Vegetable Oils Capsules Vitamin B-6
Tablets Vitamin B-12
in a Special Base Tablets Super
B-Complex Plus C Capsules Dry Aqua-E
Tablets Bone Meal Plus
Vitamin D and Iron Tablets Proportioned
Magnesium Tablets Chewable Tasti
C with Bioflavanoid Wafers |
150080- 150081 |
Vitaminerals,
Inc. |
Data and views
on Iron indications, Use and Toxicity |
150082 |
Dorsey
Laboratories |
Neo-Calglucon
Syrup |
150083- 150084 |
Vitaminerals,
Inc. |
Information on
Magnesium. |
150085- 150087 |
Vitaminerals,
Inc. |
Information on
lipotropic substances-discussion and summary. |
150088 |
Vitaminerals,
Inc. |
Information on
vitamins, minerals and hematinic - discussion and summary |
150089 |
Cooper
Laboratories, Inc. |
Vitron-C Iron
Therapy |
150090 |
General Mills
Chemicals, Inc. |
Vitamin E |
150091 |
R.L. Gaddy |
Vita-Pep
Tablets |
150091A |
TPR
Pharmaceuticals, Inc. |
B-Tinic |
150092 |
Cooper
Laboratories, Inc. |
Supplemental
to a submission of ferrous fumarate-ascrbic acid bibliography |
150093 |
Ross
Laboratories |
Supplemental
to volume 150048. Animal data on water
soluble vitamin E. |
150094 |
General Mills
Chemicals, Inc. |
Material on
Vitamin E |
150095 |
Abbott
Laboratories |
Supplemental
submission to volumes 150039-150040. |
150096- 150104 |
Hoffman-LaRoche,
Inc. |
Summary of the
data on safety and efficacy of: Vitamin A, Thiamine, Riboflavin, Niacin,
Vitamin B-6, Pantothenic Acid, Ascorbic Acid, Vitamin E, Biotin. |
150105 |
Smith, Kline
& French Laboratories |
Triamterene |
150106 |
E.R. Squibb
& Sons, Inc. |
Supplemental
submission on Theragran Tablets and Thergran-M Tablets. |
150107 |
Hoffman-LaRoche,
Inc. |
Absorption
techniques and absorption data on vitamins in pharmaceutical products. |
150108 |
Hoffman-LaRoche,
Inc. |
Manufacturing
overages of vitamins in pharaceutical products. |
150109 |
Hoffman-LaRoche,
Inc. |
Critical
review of vitamin C -sodium ascorbate: Sodium warning recommended by the OTC
VMH Panel. |
150110 |
Hoffman-LaRoche,
Inc. |
Critical
review of OTC Panel addendum to Vitamin C review P. 5 under “B. Kidney or Bladder Stones”. |
150111 |
Eastman Chemical
Products, Inc. |
Supplemental
submission on data and views of vitamin E. |
150112 |
Hoffman-LaRoache,
Inc. |
Summary data
on multi-vitamins |
150113 |
Hoffman-LaRoache,
Inc. |
Supplemental
submission on “High Vitamin Dose Levels in Man”. |
150114 150114A 150114B |
|
Statement
regarding safety of self-administered iron preparations. |
150115 |
Linus Pauling
Institute of Science & Medicine |
Pertinent
research articles |
150116 |
Wilmer, Cutler
& Pickering |
Memorandum - 3
copies to this office submitted on behalf of the council for Responsible
Nutrition |
150117 |
Hoffman-LaRoche,
Inc. |
Vitamin items |
150118 |
Marion
Laboratories, Inc. |
Oyster shells,
OS-CAL |
150119 |
Marion
Laboratories, Inc. |
OS-CAL Tabs
and Calcium carbonate |
150120 |
Merrell-National
Laboratories |
Simron: Elem
iron 10mg |
150121 |
OTC
Volume-collection of unpublished data |
|
150122 |
Marion
Laboratories, Inc. |
OS-CAL
tablets, calcium 250mg ergocalciferol (125 USP units) |
150123 |
Hoffman-LaRoche,
Inc. |
OTC Vitamin,
and Hematinic Products (Vitamin A, B12, C, E, K, biotin) |
150123A |
Hoffman-LaRoche,
Inc. |
Biotin |
150123B |
Hoffman-LaRoche,
Inc. |
Vitamin E |
150124 |
Hoffman-LaRoche,
Inc. |
OTC Vitamin,
Mineral, and Hematinic Products |
150125 |
FDA |
OTC Drug
Literature Program Part I thru VI, October 15, 1973 |
150126 |
Philadelphia Dry
Yeast Co. |
Debittered
Brewers Dry Yeast |
150127 |
The
Proprietary Association |
Draft Report
Number 8 |
150128 |
ICI Americas,
Inc. |
Calcium
sulfate as a source of calcium |
150129 |
Marion
Laboratories, Inc. |
Calcium
carbonate, OS-CAL |
150130 |
FDA |
OTC Drug
Literature Program Part I. Vitamins,
General December 10,
1973 |
150131 |
FDA |
OTC Drug
Literature Part II. Vitamins A,D,E |
150132 |
FDA |
OTC Drug
Literature Program Part III. Pages 1-300 A. Cyanocobalamin B. Folic Acid C. Niacin D. Pantothenic Acid E. Pyridoxine HCL F. Riboflavin G. Thiamine HCL H. Vitamin B Complex |
150133 |
FDA |
OTC Drug
Literature Program Part
III. Pages 301-600 |
150134 |
FDA |
OTC Drug
Literature Program Part
III. Pages 601-865 |
150135 |
FDA |
OTC Drug
Literature Program Part
IV. Ascorbic Acid |
150136 |
FDA |
OTC Drug
Literature Program Part
V. Biotin,
Choline, Inositol |
150137 |
FDA |
OTC Drug
Literature Program Part
VI. Hematinics,
Minerals. A. Calcium Salts B. Copper Salts C. Iodine D. Iron Salts E. Magnesium Salts F. Phosphorus Salts G. Zinc Salts |
150138 |
FDA |
OTC Drug
Literature Part I thru
VI. January 11, 1974 |
150139 |
FDA |
Index of
Submissions and Ingredients to VMH Panel (Breakdown of the volumes by product
and Ingredients) |
Contents |
|
150140 |
A |
150141 |
Ba - B1 |
150142 |
Bm - Bz |
150143 |
Ca – Cn |
150144 |
Co – Cz |
150145 |
D |
150146 |
E |
150147 |
F |
150148 |
G |
150149 |
H – Ha |
150150 |
Hb – Hz |
150151 |
I – J |
150152 |
K |
150153 |
L |
150154 |
Ma – Mc |
150155 |
Me – Mz |
150156 |
N |
150157 |
O |
150158 |
P |
150159 |
Ra – Ri |
150160 |
Rj – Rz |
150161 |
Sa – Sc |
150162 |
Sd – Sl |
150163 |
Sm – Sz |
150164 |
T |
150165 |
U – V |
150166 |
W |
150167 |
X – Z |
150168 |
A – B |
150169 |
C – Z |
150PA1 |
Panel
Administrator’s File (Correspondence
File), Volume 1 Contents 1.0 Table of Contents 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Members 1.4 General and Specific Charges 1.5 Summary Minutes 1.6 Interim Report 1.7 List if Panel Submissions 1.8 Regulatory Analysis Assessment 1.9 Statement of Exemption and
Environmental Assessment Reports |
150PA2 |
Panel
Administrator’s File ( Correspondence File), Volume II (1972 – 1973) |
150PA3 |
Panel Administrator’s
File (Correspondence File), Volume III (1974) |
150PA4 |
Panel
Administrator’s File ( Correspondence File),
|
150PA5 |
Panel
Administrator’s File (Correspondence File), Volume V (1976) |
150PA6 |
Panel
Administrator’s File (Correspondence File), Volume VI (1977) |
150PA7 |
Panel
Administrator’s File (Correspondence File), Volume VII (1978) |
External Analgesic Drug
Products
For OTC Human Use;
Establishment of a
Monograph and Reopening of
Administrative Record;
OTC Drug Products for the
Treatment of Diaper Rash
Part I
Docket No. 78N-0301
Index to OTC Volumes
Submitted By |
Marketed Products/Subject |
|
160021 |
Pfizer
Pharmaceuticals |
Desitin
Ointment |
160025 |
Corona
Manufacturing Co. |
|
160027 |
Warren-Teed
Pharmaceuticals, Inc. |
Taloin Diaper
Rash Ointment |
160028 |
The UpJohn Co. |
Clocream Skin
Cream |
160038 |
Miles
Laboratories, Inc. |
Acid Mantle
Crème, Acid Mantle Lotion |
160040 |
Resinol
Chemical Co. |
Resinol
Ointment, Resinol Greaseless Cream |
160041 |
Macsil, Inc. |
Balmex
Ointment |
160042 |
Syntex
Laboratories, Inc. |
Methakote
Diaper Rash Crème |
160053 A&B |
Chesebrough-Pond’s,
Inc. |
Vaseline Pure
Petroleum Jelly |
160067 |
Block Drug
Co., Inc. |
Tashan Super
Skin Cream |
160069 |
Cooper
Laboratories, Inc. |
Aveeno
Colloidal Oatmeal |
160070 |
Cooper
Laboratories, Inc. |
Aveeno
Colloidal Oatmeal |
160077 |
Bristol Myers
Co. |
Ammens Powder |
160088 |
Macsil, Inc. |
Balmex
Ointment |
160091 |
Bristol Myers
Co. |
Ammens Powder |
160104 |
USV
Pharmaceutical Corp. |
Pathoderm
Cream, Panthoderm Lotion |
160204 |
USV
Pharmaceutical Corp. |
Panthoderm
Cream Panthoderm Lotion |
160221 |
Corona
Manufacturing Co. |
|
160236 |
Pennwalt Corp. |
Caldesene
Powder, Caldesene Ointment, Proposed Product Containing Calcium Undecylenate
and Hydrocortisone Acetate |
160242 through
160247 |
Sterling Drug
Inc. |
Diaparene
Ointment, Diaparene Peri Anal, Diaparene Baby Lotion, Diaparene Medicated
Baby Powder, Diaparene Diaper Rinse Solution, Diaparene Diaper Rinse Tablets,
Diaparene Diaper Rinse Granules |
160271 |
Whitehall
Laboratories, Inc. |
Sperti Healing
Ointment |
160272 |
Whitehall
Laboratories, Inc. |
Sperti Healing
Ointment |
160277 |
American Home
Products Corp. |
Sperti Healing
Ointment |
160357 |
Stiefel
Laboratories, Inc. |
Zeasorb Super
Absorbent Medicated Powder |
160362 |
|
Corn Starch
Study |
160421 |
Macsil, Inc. |
Balmex
Ointment |
160427 |
Glenbrook
Laboratories |
Cornstarch
Study |
External Analgesic Drug
Products
For OTC Human Use;
Establishment of a
Monograph and Reopening of
Administrative Record;
OTC Drug Products for the
Prevention of Poison Ivy,
Oak,
and Sumac
Part II
Docket No. 78N-0301
Index to OTC Volumes
Submitted By |
Product |
|
160074 |
Manidn Health
and Safety, Inc. |
|
160103 |
Unimed, Inc. |
Residerm
(Poison Ivy Lotion) |
160132 |
Marion Health
and Safety, Inc. |
Zircreme, Ferric
Chloride, Sting Kill |
160152 |
Marion Health
and Safety, Inc. |
|
External Analgesic Drug
Products
for
OTC Human Use; Establishment of a
Monograph and Reopening of
Administrative Record;
OTC Drug Products for the
Treatment of Fever Blisters
Part III
Docket No. 78N-0301
Index to OTC Volumes
Submitted By |
Product |
|
160008 |
Commerce Drug
Co., Inc. |
Bio-Stik |
160012 |
Commerce Drug
Co., Inc. |
Tanac |
160013 |
Commerce Drug
Co., Inc. |
Tanac Stik |
160048 |
Campbell
Laboratories, Inc. |
Herpecin-L |
160096 |
Blistex, Inc. |
Blistex
Ointment |
160136 |
Sterling Drug
Inc. |
Campho-Phenique |
160177 |
International
Pharmaceutical Corp. |
Gly-Oxide
Liquid |
160197 |
Oral
Prophylactic Assoc., Inc. |
Mouth Komfort |
160213 |
Blistex, Inc. |
Blistik Lip
Balm |
160218 |
Glenbrook
Laboratories |
Campho-Phenique |
160231 |
Sterling Drug,
Inc. |
Campho-Phenique |
External Analgesic Drug
Products
For OTC Human Use;
Establishment of a
Monograph and Reopening of
Administrative Record
Published in the Federal
Register on
September 7, 1982 (47 FR 39412)
Part III
Statement on OTC Drug
Products
For the Treatment of Fever
Blisters
Docket No. 78N-0301
06BPA8 |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submission 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 References |
Administrative File
Alcohol Products For Topical
Antimicrobial OTC Human Use
Docket No 75N-0183
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
Index of OTC Volumes
Docket No. 75N-0183
Submitted
By |
Subject |
|
160025 |
Corona Manufacturig Co. |
Parachlormercuriphenol |
160085 |
Hynson, Westcott & Dunnig, Inc. |
Merbromin |
160154 |
Marion Health and Safety, Inc. |
Merbromin |
160157 |
Marion Health and Safety, Inc. |
Thimerosal |
160160 |
Marion Health and Safety, Inc. |
Orthohydroxyphenyl mercuric chloride |
160188 |
Bowman Pharmaceuticals, Inc. |
Ammoniated mercury |
160189 |
Bowman Pharmaceuticals, Inc. |
Thimerosal |
160224 |
Hynson, Westcott & Dunning, Inc. |
Merbromin |
160235 |
Corona Manufacturing Co. |
Merbromin |
160240 |
Eli Lilly and |
Thimerosal |
160270 |
Hynson, Westcott & Dunnig, Inc. |
Merbromin |
160271 |
|
Phenylmercuric Nitrate |
16HPA1-A |
|
Cited References |
16HPA1-B |
|
Miscellaneous Uncited References |
OTC Mercury-Containing Drug Products for
Topical Antimicrobial Use
Docket No. 75N-0183
Panel Administrator’s File
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of panel Members nd Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
Alcohol Drug Products for Topical Antimicrobial
OTC Human Use
Index to OTC Volumes
(Docket No. 75N-0183)
Submitted
By |
||
160045 |
Parke, Davis & Company |
Lavacol |
160084 |
Sea Breeze Laboratories, Inc. |
Sea Breeze |
160107 |
Cramer Products, Inc. |
Fung-O-Spray |
160148 |
Marion Health and Safety, Inc. |
Isopropanol Sepps 70/10 |
160155 |
Marion Health and Safety, Inc. |
Isopropanol 70 percent |
160173 |
Holland Rantos Company, Inc. |
Steri Wipe Alcohol Swabs |
160184 |
Bowman Pharmaceuticals, Inc. |
Isopropyl alcohol 70 percent |
160185 |
Bowman Pharmaceuticals, Inc. |
Isopropyl alcohol 91 percent |
160206 |
Holland Rantos Company, Inc. |
Ethylene Oxide in 70 percent Isopropyl alcohol |
160207 |
Eli Lilly and Company |
Isopropyl alcohol 91 percent |
160209 |
Eli Lilly and Company |
Isopropyl alcohol 91 percent |
160249 |
Cramer Products, Inc. |
Nitrotan |
160250 |
Cramer Products, Inc. |
Nitrotan (Aerosol) |
160251 |
Cramer Products, Inc. |
Iso-Quin |
160278 |
Whitehall Laboratories, Inc. |
Anbesol |
160377 |
Vestal Laboratories |
Alcare |
160382 |
Vestal Laboratories |
Alcare |
16JPA1-A |
|
Cited References |
16JPA1-B |
|
Uncited References |
OTC Skin Bleaching Products
|
||
Plough, Inc. |
||
Chattem Drug & Chemical Co. |
||
Nicholas Products Ltd. |
||
(Animal Safety Data, Part 1) |
||
(Animal Safety Data, Part 2) |
||
(Medical rationale) |
||
(Effectiveness data) |
(Vol. V) |
|
(Human safety data) |
(Vol. IV) |
|
References |
|
1. Federal Register call for data
2. List of Panel members and curricula vitae
3. General charge to OTC Drug Products Review Panels
4. Statement of Exemption and Environmental Assessment Report
5. Economic Impact Assessment Statement
6. Minutes of the Miscellaneous External OTC Drug Products Review Panel
7. Correspondence to the FDA staff or Panel on these drug – None.
There is no Panel Administrator’s File Volume II
Nailbiting and Thumbsucking Deterrent
Drug Products Panel Index
Submitted
By |
Subject |
|
160010 |
Commerce Drug Co., inc. |
Sucrose Octaacetate Isopropyl Alcohol |
160020 |
The Mentholatum Co., Inc. |
Sucrose Octaacetate Denatonium Benzoate |
160054 |
Purepac Pharmaceutical Co. |
Denatonium Benzoate |
160168 |
Parke Davis & Co. |
Sucrose Octaacetate |
160172 |
Parke Davis & Co. |
Denatonium Benzoate |
160228 |
Parke Davis & Co. |
Denatonium Benzoate |
160295 (2 Volumes) |
International Research and Development Corporation |
Denatonium Benzoate |
Nailbiting and Thumbsucking Deterrent
Drug Products Panel Index
Subject |
|
160416 |
Cited References |
160417 |
Miscellaneous Uncited References |
Administrative File
OTC Nailbiting and Thumbsucking Deterrent Drug Products
Docket No. 80N-0146
Panel Administrator’s File
16DPA1 |
Panel Administrator’s File 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File |
Camphorated Oil and Camphor-Containing Products Panel Index
Submitted
By |
Subject |
|
160291 |
American Pharmaceutical Association |
Camphorated Oil |
160383 |
Carmine Varane, Pharmacist |
Camphorated Oil |
PANEL SUBMISSIONS ON OTC MISCELLANEOUS EXTERNAL DRUGS PRODUCTS CONCERNING OTC DRUG PRODUCTS CONTAINING CAMPHOR REGARDING RE-OPENING OF RECORD OF RECORD FOR EXTERNAL ANALGESIC 78N-0301; ANORECTAL DRUG PRODUCTS 80N-0050; AND COUGH-COLD 76N-0052
Volume |
Submitted
By |
Subject |
160222 |
University of |
Camphor |
160358 |
University of |
Camphor |
Administrative File
OTC Camphorated Oil and Camphor-Containing Drug Products
Dockets No 80N-0227
Contents |
|
16BPA1 |
1.0 References 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 Index to Panel Submissions 1.5 Regulatory Analysis Assessment 1.6 Summary Minutes of Panel Meetings 1.7 Correspondence File |
Miscellaneous External Advisory Review Panel Index For
OTC Wart
Remover Drug Products Submissions
Submitted
By |
||
160004 |
Whitehall Laboratories, Inc. |
Compound W |
160007 |
Commerce Drug Co., Inc. |
B-D-B Wart Remover |
160282 |
Whitehall Laboratories, Inc. |
Literature References |
160283 |
Whitehall Laboratories, Inc. |
Supplemental Data—Studies Pertaining to Salicylic Acid, Glacial Acetic Acid, Acetone Collodion,and Collodion |
160287 |
Daywell Laboratories Corp. |
Vergo |
160289 |
Stiefel Laboratories, Inc. |
Duofilm |
160359 |
Stiefel Research Institute, Inc. |
Duofilm-C |
160376 |
Dr. Mary H. Bunney Royal Infirmary |
Supplemental Data—Studies Using Salicylic Acid and Lactic Acid |
160411 |
|
Cited References |
160412 |
|
Miscellaneous Uncited References |
Administrative File
Wart Remover Drug Products for Over-the-Counter Human Use
Docket No. 80N-0238
Panel Administrator’s File
Contents |
|
16CPA1 |
Panel Administrator’s File 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File |
Ingrown Toenail Relief Drug Products Panel Index
Submitted
By |
Subject |
|
160100 |
Scholl, Inc. |
Sodium Sulfide |
160127 |
|
Chlorobutanol, Tannic Acid, Isopropyl Alcohol |
160280 |
Scholl, Inc. |
Sodium Sulfide |
160384 |
|
Chlorobutanol, Tannic Acid, Isopropyl Alcohol |
160386 |
Scholl, Inc. |
Sodium Sulfide |
160419 |
|
Cited References |
160420 |
|
Miscellaneous Uncited References |
Administrative File
OTC Ingrown Toenail Relief Drug Products
Docket No. 80N-0348
Panel Administrator’s File
Contents |
|
16EPA1 |
Panel Administrator’s File 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File |
Hair Grower and Hair Loss Prevention Drug Products Panel Index
Submitted
By |
Subject |
|
160118 |
Edwards Industrial Center, Inc. |
Tetracaline Hydrochloride, Benzoic Acid, Ascorbic Acid |
160232 |
Shepard D. Roberts |
Lanolin, Wheat Germ Oil, Coconut Oil, Vegetable Olive Oil |
160425 |
|
Cited References |
160426 |
|
Miscellaneous Uncited References |
Administrative File
OTC Hair Grower and Hair Loss Prevention Drug Products
Docket No. 80N-0357
Panel Administrator’s File
16FPA1 |
Panel Administrator’s File 1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File |
Corn and Callus Remover Drug Products
Index to OTC Volumes
Submitted
By |
Products/Subject |
|
160003 |
|
Freezone |
160073 |
Chattem Drug & Chemical Co. |
Blis-To-Sol |
160079 |
E.G. Behren |
Corn Callus Remover |
160097 |
Scholl, Inc. |
“2” Drop Corn/Callous Remover, Callous Salve, Corn Salve, Halluxol, Onixol and Corn and Callous Products |
160098 |
Scholl, Inc. |
Same as 160097 |
160099 |
Scholl, Inc. |
Same as 160097 |
160100 |
Scholl, Inc. |
Same as 160097 |
160101 |
Scholl, Inc. |
Same as 160097 |
160133 |
|
Freezone |
160256 |
Scholl, Inc. |
A report on “Outpatient Utilization of ICPM Foot Clinic” |
160282A & B |
|
Salicylic acid |
160283 |
|
Zinc chloride, salicylic acid, and acetic acid |
160285 |
Scholl, Inc. |
Salicylic acid |
160292 |
Combe, Inc. |
Blue Jay Corn Plasters |
160293 |
Scholl, Inc. |
40 percent salicylic acid disks |
160294 |
Combe, Inc. |
Phenoxyacetic acid |
160380 |
Scholl, Inc. |
Salicylic acid |
160398 |
Combe, Inc. |
Phenoxyacetic acid |
16IPA1-A |
|
Cited References |
16IPA1-B |
|
Uncited References |
Administrative File
OTC Corn and Callus Remover Drug Products
Docket No. 81N-0122
Panel Administrator’s File
16IPA1 |
1.1 Call to Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
Topically Applied Hormone-Containing Drug Products
Index of OYC Volumes
(Docket No. 81N-0144)
Submitted
By |
||
160055 |
Sterling Drug, Inc. |
Satura Moisture Cream with Hormones; Satura Moisture Lotion with Hormones; Moisturing Hormone Hand Cream; Cellogen Moisturing Hormone Cream with Protein Hydrolysate |
160057 |
USV Pharmaceutical Corporation |
Hormonex Beauty Serum; Hormonex in Cream; Hormonex hair and Scalp Serum |
160095 |
Helena Rubinstein |
Ultra Feminine Cream with Natural Estrogen and Progesterone; Ultra Feminine beauty Oil with Natural Estrogen and Progesterone |
160195 |
FDA, Bureau of Drugs Office of Compliance |
Information to the Panel regarding potential hazard of topical skin and hair preparations containing various hormones. |
16GPA1-A |
|
Cited References |
Administrative File
Topically Applied Hormone-Containing Drug Products
For Over-The-Counter Human Use
(Docket No. 81N-0144)
Panel Administrator’s File
Contents |
|
16GPA1 |
1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
Pediculicide Drug Products for OTC Human Use
Index of OTC Volumes
(Docket No. 81N-0201)
Submitted
By |
Products/Subject |
|
160011 |
Commerce Drug Company, Inc. |
BARC Cream and Liquid |
160046 |
Norcliff laboratories, Inc. |
A-200 Pyrinate Liquid and Gel |
160075 |
Block Drug Company, Inc. |
Dolex Gel and Foaming Liquid |
160092 |
McKesson laboratories |
A-200 Pyrinate Liquid and Gel |
160094 |
Norcliff Laboratories, Inc. |
Kerosene |
160130 |
FMC Corporation |
Efficacy data on piperonyl butoxide—pediculosis control. |
160137 |
Pfizer Pharmaceuticals, Inc. |
RID |
160138 |
Pfizer Pharmaceuticals, Inc. |
RID |
160163 |
Pfizer Pharmaceuticals, Inc. |
RID |
160202 |
Norcliff Thayer, Inc. |
A-200 Pyrinate Liquid and Gel |
160217 |
Block Drug Company, Inc. |
Dolex |
160220 |
Block Drug Company, Inc. |
Dolex |
160227 |
Pfizer Pharmaceuticals, Inc. |
RID |
160264 |
|
A-pyrenone—pediculosis control |
160279 |
Pfizer Pharmaceuticals, Inc. |
RID |
160360 |
Pfizer Pharmaceuticals, Inc. |
RID |
160400 |
Norcliff Thayer, Inc. |
A-200 Pyrinate Liquid and Gel |
160403 |
Laboratories Applipharm SA |
PARA-2 |
16KPAI-A |
|
Cited References |
16KPAI-B |
|
Uncited References |
Administrative File
Pediculicide Drug Products For
OTC Human Use
Docket No. 81N-0201
Panel Administrator’s File
Contents |
|
16KPAI |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
Boil Ointment Drug Products for OTC Human Use
Index to OTC Volumes
(Docket No. 82N-0054)
Submitted
By |
Products/Subject |
|
160005 |
Commerce Drug, Co., Inc. |
Boil-Ease |
160182 |
Bowman Pharmaceuticals, Inc. |
Bowman Drawing Paste |
160214 |
Press Chemical and Pharmaceutical Laboratories, Inc. |
Epsal Ointment |
16LPA1-A |
|
Cited References |
Administrative File
Boil Ointment Drug Products for OTC Human Use
Docket No 82N-0054
Contents |
|
16LPA1 |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record;
OTC Drug Products for the Treatment of Diaper Rash
Part I
Docket No. 78N-0301
Index to OTC Volumes
Submitted
by |
Marketed
Products/Subject |
|
160021 |
Pfizer Pharmaceuticals |
Desitin Ointment |
160025 |
Corona Manufacturing Co. |
|
160027 |
Warren-Teed Pharmaceuticals, Inc. |
Taloin Diaper Rash Ointment |
160028 |
The UpJohn Co. |
Clocream Skin Cream |
160038 |
Milies Laboratories, inc. |
Acid Mantle Cream, Acid mantle Lotion |
160040 |
Resinol Chemical Co. |
Resinol Ointment, Resinol Greaseless Cream |
160041 |
Macsil, Inc. |
Balmax Ointment |
160042 |
Syntex laboratories, Inc. |
Methakote Diaper Rash Crème |
160053 |
Chesebrough-Pond’s, Inc. |
Vaseline Pure Petroleum Jelly |
160067 |
Block Drug Co. Ic. |
Tashan Super Skin Cream |
160069 |
Cooper Laboratories, Inc. |
Aveeno Colloidal Oatmeal |
160070 |
Cooper Laboratories, Inc. |
Aveeno Colloidal Oatmeal |
160077 |
Bristol Myers Co. |
Ammens Powder |
160088 |
Macsil, Inc. |
Balmax Powder |
160091 |
Bristol Myers Co. |
Ammens Powder |
160104 |
USV Pharmaceutical Corp. |
Panthoderm Cream, Panthoderm Lotion |
160204 |
USV Pharmaceutical Corp. |
Panthoderm Cream Panthoderm Lotion |
160221 |
|
|
160236 |
Pennwalt Corp. |
Caldesene powder, Caldesene Ointment, Proposed Product Containing Calcium Undecylenate and Hydrocortisone Acetate |
160242 through 160247 |
Sterling Drug Inc. |
Diaparene ointment, Diaparene peri Anal, Diaparene Baby Lotion, Diaparene Medicated Baby Powder, Diaparene Diaper rinse Solution, Diaparene Diaper Rinse Tablets, Diaparene Diaper Rinse Granules |
160271 |
Whitehall Laboratories, inc. |
Sperti Healing Ointment |
160272 |
Whitehall Laboratories, Inc. |
Sperti Healing Ointment |
160277 |
American Home Products Corp. |
Sperti Healing Ointment |
160357 |
Stiefel Laboratories, Inc. |
Zeasorb Super Absorbent Medicated Powder |
160362 |
|
Corn Starch Study |
160421 |
Macsil, Inc. |
Balmax Ointment |
160427 |
Glenbrook laboratories |
Cornstarch Study |
Administrative File
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record
Published in the FEDERAL REGISTER on
September 7, 1982
(47 FR 39412)
Part I
Statement on OTC Drug Products
For the Treatment of Diaper Rash
Docket No. 78N-0301
Panel Administrator’s File
Contents |
|
06BPA6 |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 Cited References 1.9 Uncited References |
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record;
OTC Drug Products for the Prevention of Poison Ivy,
Oak, and Sumac
Part III
Docket No. 78N-0301
Index to OTC Volumes
Submitted
By |
Product |
|
160103 |
Unimed, Inc. |
Residerm (Poison Ivy Lotion) |
160132 |
Marion Health and Safety, Inc. |
Zircreme,. Ferric Chloride, Sting-Kill |
160152 |
Marion Health and Safety, Inc. |
|
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record;
OTC Male Genital Desensitizing Drug products
Part IV
Docket No. 78N-0301
Index to OTC Volumes
Sumitted
By |
Product |
|
160001 |
Frederick Damrau, MD |
Culminal |
160014 |
Commerce Drug Co., Inc. |
Detane |
160171 |
Ciba-Geigy Corp. |
Nupercainal Ointment |
160260 |
Keller and Heckman for Pound International Corp. |
Stud-100 |
160266 |
Keller and Heckman for Pound International Corp. |
Stud-100 |
160281 |
|
Detane |
160290 |
Commerce Drug Co., Inc. |
Detane |
160388 |
|
Detane |
06BPA9-A |
|
Cited References |
06BPA9-B |
|
Uncited References |
Administrative File
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record
Published in the FEDERAL REGISTER on
September 7, 1982 (47 FR 39412)
Part IV
Statement on OTC Male Genital Desensitizing Drug Products
Docket No. 78N-0301
Panel Administrator’s File
06BPA9 |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record;
OTC Astringent Drug Products
Part V
Docket No. 78N-0301
Index to OTC Volumes
Submitted
By |
Marketed
Products/Subject |
|
160022 |
Marion Laboratories Inc. |
Bluboro Powder |
160038 |
Dome Laboratories |
Acid Mantle, Crème, Lotion |
160039 |
Dome Laboratories |
Domeboro Tablets, Powder |
160069 |
Cooper Laboratories, Inc. |
Acnaveen Bar, Cream, Aveeno Bar, bath, Oilated Bath, Avenol Bath Additive, BurVeen Wet Dressing Powder, Emulave bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo |
160070 |
Cooper Laboratories, Inc. |
Acnaveen bar, Cream, Aveeno Bar, bath, Oilated bath, Avenol bath Additive, Bur Veen Wet Dressing Powder, Emulave bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo |
160093 |
R.L. Gaddy |
Ez-It Medicated Foot Powder |
160140 |
Marion Laboratories, Inc. |
Bluboro Powder |
160219 |
Marion Laboratories, Inc. |
Bluboro Powder |
160230 |
Marion Laboratories, Inc. |
Bluboro Powder |
160233 |
Cox Drugs |
Formula “U” |
160354 |
Humpheys Pharmacel, Inc. |
Witch Hazel |
160396 |
Stiefel Research Institute, Inc. |
AluWets |
160409 |
Perito, Duerk, Carlson & Pinco for Requa Manufacturing Co., Inc. |
Aluminum Sulfate Styptic Pencil |
160413 |
The Woltra Company, Inc. |
Aluminum Sulfate Styptic Pencil |
160428 |
The E. E. Dickinson Co. |
Witch Hazel |
160429 |
Beecham Products |
OTC Astringent Vaginal Douche Drug Products |
160433 |
American Distilling and Manufacturig Co., Inc. |
Witch Hazel Study |
160435 |
Requa manufacturing Co., Inc. |
Aluminum Sulfate |
06BPA10-A |
|
Cited References |
06BPA10-B |
|
Uncited References |
Administrative File
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record
Published in the FEDERAL REGISTER on
September 7, 1982
(47 FR 39412)
Part V
Statement on OTC
Astringent Drug Products
Docket No. 78N-0301
Panel Administrator’s File
06BPA10 |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence |
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record;
OTC Insect Bite Neutralizer Drug Products
Part VI
Docket No. 78N-0301
Index to OTC Volumes
Submitted
By |
||
160074 |
Marion Health and Safety, Inc. |
Sting Kill Swabs |
160119 |
Tender Corp. |
After Bite |
160159 |
Marion Health and Safety, Inc. |
Sting Kill Swabs |
160434 |
Tender Corp. |
After Bite |
Administrative File
External Analgesic Drug Products
For OTC Human Use; Establishment of a
Monograph and Reopening of Administrative Record
Published in the FEDERAL REGISTER on
September 7, 1982
(47 FR 39412)
Part VI
Statement on OTC Insect Bite Neutralizer Drug Products
Docket No. 78N-0301
Panel Administrator’s File
Contents |
|
06BPA11 |
1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 References |
OTC Drug Products for the Control of Dandruff
Saborrheic Dermatitis, and Psoriasis;
Establishment of Monograph
Docket No. 82N-0214
Index to OTC Volumes
Submitted
By |
Marketed Products/Subject |
|
160033 |
Denver Chemical Mfg. Co. |
Siroil |
160042 |
Syntex Laboratories, Inc. |
Methakote |
160043 |
Reed and Carnrick |
Tarbonis |
160047 |
Reed and Carnrick |
Alphosyl |
160050 |
Reed and Carnrick |
Sebical Anti-dandruff Shampoo |
160051 |
Westwood Pharmaceuticals, Inc. |
Balnetar |
160059 |
Purex Corp., Ltd |
Cuticura medicated Liquid |
160060 |
Purex Corp., Ltd |
Cuticura Medicated Ointment |
160068 |
Block Drug Co., Inc. |
Terin Cream, Tegrin Foam, Tegrin Medicated Soap |
160069 |
Cooper Laboratories, Inc. |
Acnaveen Cream, Packer’s Pine Tar Liquid Shampoo, Packer’s Pine Tar Soap, Sebaveen |
160070 |
Cooper Laboratories, Inc. |
Supplemental data |
160087 |
Westwood Pharmaceuticals, Inc. |
Supplemental data |
160129 |
|
Oxipor VHC Lotion |
160134 |
|
Denorex Medicated Gel Shampoo, Denorex Medicated Liquid Shampoo |
160201 |
Chester A. Baker Laboratories, Inc. |
Baker’s P & S Liquid, Baker’s P & S Ointment |
160237 |
Mitchum-Thayer, Inc. |
Mazon Medicated Cream |
160238 |
Mitchum-Thayer, Inc. |
Mazon Medicated Soap |
160241 |
|
Oxipor VHC Lotion |
160253 |
Westwoord Pharmaceuticals, Inc. |
Estar Therapeutic Tar Gel |
160255 |
H.B. Distributing |
Hospital Brand Psoriasis Emulsion |
160267 |
Dr. Zackman |
Letter of Communication on coal tar |
160275 |
Warner Lambert Co. |
Listerine Antiseptic |
160276 |
Warner Lambert Co. |
Listerine Anitseptic |
160286 |
The Proprietary Association |
Coal tar Products |
160297 |
Preston Pharmaceuticals, Inc. |
Dermakon Dandruff Shampoo |
160298/ 160299 |
Texas Pharmacal Co. |
Meted Cream Shampoo, Meted Lotion Shampoo |
160300 |
Armour-Dial, Inc. |
Dial Conditioning Dandruff Shampoo for Normal Hair, Dial Conditioning Shampoo for Dry hair, Dial Conditioning Shamposs for Oily Hair |
160301 |
Armour-Dial, Inc. |
References |
160302 |
Armour-Dial, Inc. |
References |
160303 |
Armour-Dial, Inc. |
References |
160304 |
Procter and Gamble |
Head and Shoulders |
160305 |
Mitchum-Thayer, Inc. |
Mitchum Dandruff Shampoo |
160306 |
Max Factor |
Sebb Lotion |
160307 |
Mitchum-Thayer, Inc. |
Mazon Medicated Shampoo |
160308 |
H. Clay Glover Co., Inc. |
Glover’s Imperial Scarcoptic Mange Medicine |
160309 |
H. Clay Glover Co., Inc. |
Glover’s Imperial Medicated Soap |
160310 |
H. Clay Glover Co., Inc. |
Glover’s Imperial Medicated Ointment |
160311 |
Marion Laboratories, Inc. |
Metasep Medicated Shampoo |
160312 |
Olin Corp. |
Zinc Omadine |
160313 |
Flow Pharmaceuticals |
Nu-Flow |
160314 |
Alcon Laboratories, Inc. |
Ionil, Ionil-T |
160315 |
|
Denorex Medicated Liquid Shampoo |
160316 |
G.S. Herbert Laboratories |
Vanseb Dandruff Shampoo, Vanseb-T Tar Shampoo |
160317 |
Hess Hair Milk Laboratories, Inc. |
Hess Hair Milk |
160318 |
Texas Pharmacal Co. |
Meted-2 Cream Shampoo, Meted-2 Lotion Shampoo |
160319 |
Sterling Drug, Inc. |
Cradol |
160320 |
Sterling Drug, Inc. |
Methylbenzethonium chloride |
160321 |
Sterling Drug, Inc. |
Double Danderine |
160322 |
Sterling Drug, Inc. |
Phisoden |
160323 |
Westwood Pharmaceuticals, Inc. |
Sebulex Conditioning Shampoo |
160324 |
Westwood pharmaceuticals, Inc. |
Foxtex Cream |
160325 |
Westwood Pharmaceuticals, Inc. |
Sebutone AntiSEBORRHEIC Tar Shampoo |
160326 |
R. Schattner Co., Pharmaceuticals |
Chloraderm |
160327 |
Smith, Kline, and French Laboratories |
Pragmatar |
160328 |
H. Clay Glover Co., Inc. |
Supplemental data Glover’s Imperial Medicated Soap |
160329 |
H. Clay Glover Co., Inc. |
Supplemental data Glover’s Imperial Medicated Ointment |
160330 |
H. Clay Glover Co., inc. |
Supplemental data Glover’s Imperial Sarooptic Mange Medicine |
160331 |
Purdue Frederick Co. |
Betadine Shampoo |
160332 |
Colgate-Palmolive |
Grenadier Dandruff Control hair Groom, Wildroot Dandruff Treatment hair Groom |
160333 |
Colgate-Palmolive |
Look Twice Anti-dandruff Shampoo |
160334 |
Colgate-Palmolive |
Look Twice Anti-dandruff Shampoo |
160335 |
Colgate-Palmolive |
Safety and efficacy of zinc pyrithione |
160336 |
Colgate-Palmolive |
Supplemental data |
160337 |
Colgate-Palmolive |
Supplemental data |
160338 |
H. Clay Glover Co., Inc. |
Supplemental data Glover’s Imperial Medicated Soap |
160339 |
Block Drug Co., Inc. |
Tegrin Medicated Shampoo |
160340 |
Helene Curtis Industries, Inc. |
Enden Lotion Shampoo |
160341 |
American Cyanamid Co. |
Bibliography of omadines |
160342 |
Penwalt Corp. |
Hydrocortisone acetate and calcium undecylenate |
160343 |
Hask, Inc., Toiletries |
Hask D.S.T. Treatment Shampoo |
160344 |
Hask, Inc. Toiletries |
Hask Hair and Scalp Treatment |
160345 |
h. Clay Glover Co., Inc. |
Rewocid SBU 185 |
160346 |
Gillette Medical Evaluation Laboratories |
Safety and efficacy of zinc omadine |
160347 |
Texas Pharmacal Co. |
Pentrax Tar Shampoo |
160348 |
Texas Pharmacal Co. |
Supplemental data |
160349 |
Gillette Co. |
Selenium sulfide |
160350 |
R.T. Vanderbilt Co., inc. |
Vancide 89 RE |
160351 |
Helene Curtis Industries, Inc. |
Suave Dandruff Shampoo |
160352 |
Alberto-Culver Co. |
Rinse Away Dandruff Rinse |
160353 |
Warner-Lambert Co. |
Listerine Antiseptic |
160355 |
US Borax Research |
Toxicity of Boric acid and sodium tetraborate |
160356 |
Westwood Pharmaceuticals, Inc. |
Sebulex Conditioning Shampoo |
160363 |
Abbott Laboratories |
Selsun Blue for |
160364 |
Stiefel laboratories, Inc. |
Polytar Shampoo |
160365 |
Block Drug Co., inc. |
Hydrocortisone alcohol and coal tar extract |
160366 |
Olin Corp. |
Toxicological summary of zinc omadine |
160367 |
Olin Corp. |
Bibliography I |
160368 |
Olin Corp. |
Bibliography II |
160369 |
Procter & Gamble |
Safety and efficacy of zinc pyrithione |
160370 |
Procter and Gamble |
References 1-25 |
160371 |
Procter and Gamble |
References 26-50 |
160372 |
Procter and Gamble |
References 51-75 |
160373 |
Procter and Gamble |
References 76-100 |
160374 |
Procter and Gamble |
References 101-121 |
160375 |
Westwood Pharmaceuticals, Inc. |
Supplemental data Estar Gel |
160378 |
Avon Products, Inc. |
Keep Clear Anti-dandruff Shampoo |
160379 |
Mitchum-Thayer, Inc. |
Mazon Medicated Cream |
160381 |
The Proprietary Association |
Coal tar Products |
160385 |
Abbott Laboratories |
Safety and evaluation o selenium sulfide |
160387 |
Block Drug Co., inc. |
Tegrin Shampoo |
160389 |
Procter and Gamble |
Supplemental data Head and Shoulders |
160390 |
National Cancer Institute |
Bioassay of Selsun for Possible Carcinogenicity |
160392 |
Beecham Products, Inc. |
Zinc pyrithione anti-dandruff hairgroom |
160393 |
R.T. Vanderbilt Co., inc. |
Supplemental data Vancid 89 RE |
160394 |
Emery Uncommon Chemicals |
Undeclenic acid monoethanolamide sulfosuccinate, sodium salt |
160395 |
Purdue Frederick Co. |
Supplemental data Betadine Shampoo |
160397 |
Westwood Pharmaceuticals, Inc. |
Sebucare Scalp Lotion, Supplemental data |
160401 |
Helene Curtis Industries, inc. |
Supplemental data Enden lotion Shampoo |
160402 |
Emery uncommo Chemicals |
Ogilvie Dandruff Shampoo |
160404 |
Plough, Inc. |
Sulfur-8 Hair and Scalp Conditioner |
160405 |
Helene Curtis Industries, Inc. |
Validation of the IBT Study Suave Dandruff Shampoo |
160406 |
Neutrogena Corp. |
T-Gel Shampoo |
160407 |
Stiefel Laboratories, Inc. |
Polytar Bath |
160408 |
H.B. Distributing |
Hospital Brand Psoriasis Emulsion |
160410 |
Hask, Inc., Toiletries |
Letter of communication |
160414 |
Westwood Pharmaceuticals, inc. |
Supplemental data |
160418 |
The proprietary Assocaition |
Coal tar project |
160430 |
|
Coal tar lotions |
160431 |
The Proprietary Association |
Coal tar project |
160432 |
National Psoriasis Foundation |
Coal tar |
160436 |
Dr. R.B. D’Agostino |
Statistical evaluation |
Administrative File
OTC Drug Products for the Control of Dandruff,
Seborrheic Dermatitis, and Psoriasis
Establishment of a Monograph
Published in the FEDERAL REGISTER of
December 3, 1982 (47 FR 54646)
Docket No. 82N-0214
Panel Administrator’s File
Contents |
|
16MPA1 16MPA1-A 16MPA1-B |
1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of panel Member and liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 Cited References 1.9 Uncited References |
NO_______TFM_____________ VOLUME WAS MADE FOR__Naibiting and____________________
__thumbsucking Deterrent Drug_Products _________________________________________________
NO_____TFM_____________ VOLUME WAS MADE FOR____Wart Remover________________
_Drug Products _________________________________________________________________
TFM VOLUME____16ATFM________________________________
Has been established for__Skin Bleaching Drug Products___________________________________
TFM VOLUME______16BTFM_____________________
Has been established for__Hair Grower and hair Loss
Prevention Drug Products________
TFM VOLUME____16ETFM_______________________
Has been established for____Ingrown Toenail Drug Products_______________________________________
FR VOLUME__16BFR____________________
Has been established for____Camphorated Oil Drug Products_____________________________
STOMACH ACIDIFIER ADMINISTRATIVE RECORD
(Docket No. 79N-0176)
Index to Panel Submissions
Firm |
||
170011 |
Stuart Pharmaceuticals |
Stuart Amino Acids with B12 |
170023 |
|
Acidol-Pepsin |
170049 |
Dorsey laboratories |
Kanulase Tablets |
170103 |
Eli Lilly and Company |
Acidulin (glutamic acid hydrochloride) Volume I |
170104 |
Eli Lilly and Company |
Acidulin (glutamic acid hydrochloride) Volume II |
170105 |
Stuart Pharmaceuticals |
Normacid Supplements |
170124 |
Eli Lilly and Company |
Acidulin (glutamic acid hydrochloride) |
SWEET SPIRITS OF NITRE
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(Docket No. 79N-0177)
INDEX TO PANEL SUBMISSION
Contents |
|
170163 |
1. Letter dated August 30, 1976, to Robert J. Haggerty, M.D., from Joseph P. Hile, Acting Commissioner of Food and Drugs, pertaining to sweet spirits of nitre. 2. TWX: Injury/Death Investigation, Sweet Spirits of Nitre, Complaint Form # X041-235, dated November 20, 1974. 3. TWX: Death investigation, Sweet Spirits of Nitre, dated November 22, 1974. |
170183 |
References |
170PA1 |
Panel Administrator’s File |
CHOLECYSTOKINETIC DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(Docket No. 79N-0368)
INDEX TO PANEL SUBMISSIONS
Submitted
by |
Subject |
|
170045 |
Gray Pharmaceutical Co. |
G.B.-Prep Emulsion (Corn oil) |
170184 |
|
References |
17CPAI |
|
Panel Administrator’s File |
ANTHELMINTIC DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(Docket No. 79N-0378)
Submitted
By |
||
170024 |
Sterling Drug Company |
Jayne’s PW Vermifuge |
170033 |
Pfizer Pharmaceuticals Inc. |
Antiminth Oral Suspension |
170068 |
Pfizer Pharmaceuticals Inc. |
Pyrantel Pamoate oral Suspension (Vol. 1 of 6) |
170069 |
Pfizer Pharmaceutical Inc. |
Pyrantel Pamoate Oral Suspension (Vol. 2 of 6) |
170070 |
Pfizer Pharmaceuticals Inc. |
Pyrantel Pamoate Oral Suspension (Vol. 3 of 6) |
170071 |
Pfizer Pharmaceuticals, Inc |
Pyrantel Pamoate Oral Suspension (Vol. 4 of 6) |
170072 |
Pfizer Pharmaceuticals, Inc. |
Pyrantel Pamoate Oral Suspension (Vol. 5 of 6) |
170073 |
Pfizer Pharmaceuticals, Inc. |
Pyrantel Pamoate Oral Suspension (Vol. 6 of 6) |
170101 |
Scientific Associates inc. |
Piperazine Citrate Syrup |
170122 |
Pfizer Pharmaceuticals Inc. |
Pyrantel Pamoate Oral Suspension |
170133 |
Sterling Drug Co. |
Jayne’s PW Vermifuge |
170134 |
Pfizer Pharmaceuticals Inc. |
Pyrantel Pamoate Oral Suspension |
170158 |
Pfizer Pharmaceuticals Inc. |
Pyrantel Pamoate Oral Suspension |
170160 |
Pfizer Pharmaceuticals Inc. |
Pyrantel Pamoate oral Suspension |
170161 |
Memorandum from the Division of Drug Experience to the Division of OTC Drug Evaluation |
Adverse Peactions to Antiminth, Povan, Piperazine Citrate, and Gentian Violet |
170162 |
Pfizer Internatonal |
Drug Experience Report |
170207 |
|
References |
17FPAI |
|
Panel Administrator’s File (1.1 – 1.8) |
17FPAII |
|
Panel Administrator’s File (Correspondence) |
Exocrine Pancreatic Insufficiency Drug Products
For Over-The-Counter Human Use
Administrative Record
(Docket No. 79N-0379)
Index to Panel Submissions
Submitted
By |
Subject |
|
170034 |
|
Stamyl tablets |
170130 |
Parke-Davis and Co. |
Panteric capsules, tablets, granules |
170144 |
Hoechst-Roussel Pharm. |
Festal tablets (Volume 1 of 3) |
170145 |
Hoechst-Roussel Pham. |
Festal tablets (Volume 2 of 3) |
170146 |
Hoechst-Roussel Pharm. |
Festal tablets (Volume 3 of 3 ) |
170182 |
|
References |
17BPAI |
|
Panel Administrator’s File |
Hypophosphatemia and Hyperphosphatemia Drug Products For
Over-The-Counter Human Use
Administrative Record
(Docket No. 80N-0395)
Index to Panel Submissions
Submitted
By |
Subject |
|
170005 |
Wyeth Laboratories Inc. |
Basaljel |
170043 |
Wyeth Laboratories Inc. |
Phosphaljel |
170211 |
|
References |
17HPAI |
|
Panel Administrator’s File (1.1 – 1.9) |
Smoking Deterrent Drug Products For
Over-The-Counter Human Use
Administrative Record
(Docket No. 81N-0027)
Submitted
By |
Subject |
|
170001 |
Health Sciences Association |
Nicoprive (Volume 1 of 2) |
170002 |
Health Sciences Association |
Nicoprive (Volume 2 of 2) |
170038 |
Campana Corporation |
Bantron |
170129 |
Edgefield Corporation |
Tabmint Chewing Gum |
170168 |
S.A. Cravotta Company |
“I Quit” |
170169 |
Friend, Perles, Dorfman and Kleefeld |
Nicocortyl (Volume 1 of 2) |
170170 |
Friend, Perles, Dorfman and Kleefeld |
Nicocortyl (Volume 2 of 2) |
170173 |
Buffalo District, FDA |
Nicocortyl |
170178 |
Edgefield Corporation |
Tabmint Chewing Gum |
170229 |
|
References |
17KPAI |
|
Panel Administrator’s File |
Insect Repellent Drug Products for
Over-the-Counter Oral Human Use
Administrative Record
(Docket No. 81N-0040)
Index to Panel Submissions
OTC
Volume Number |
Submitted
By |
|
170174 |
FDA |
Journal articles and textbook abstracts |
17NPAI |
FDA |
Panel Administrator’s File (1.1 – 1.8) |
Drug Products For Over-the-Counter Human Use
For the Treatment of Acute Toxic Ingestion
Administrative Record
(Docket No. 81N-0050)
Index to Panel Submission
Submitted
By |
Subject |
|
170139 |
Bowman Pharmaceuticals, Inc. |
Poison Control Kit |
170150 |
Requa manufacturing Company, Inc. |
Activated Charcoal |
170151 |
Regua Manufacturing Company, Inc. |
Activated Charcoal |
170227 |
FDA |
References (Cited and Uncited) |
170PAI |
FDA |
Panel Administrator’s File |
Orally Administered Drug Products For the
Treatment
Of Fever Blisters for Over-the-Counter Human Use
Administrative Record
(Docket No. 81N-0060)
Index to Panel Submissions
Submitted
By |
||
170052 |
Hynson, Westcott and Dunning, Inc. |
Lactinex |
170180 |
Hynson, Westcott and Dunning, Inc. |
Lactinex |
170185 |
Hynson, Westcott and Dunning, Inc. |
Lactinex |
170228 |
|
References |
17IPAI |
|
Panel Administrator’s File |
Deodorant Drug Products for Internal Use for
Over-the-Counter Human Use
Administrative File
(Docket No. 81N-0064)
Index to Panel Submissions
Submitted
By |
||
170014 |
Rystan Company Inc. |
Derifil Tablets Chloresium Tablets Activated Charcoal |
170125 |
|
Activated Charcoal |
170151 |
Requa manufacturing Co., Inc. |
Activated Charcoal |
170171 |
Parthenon Co. inc. |
Bismuth Subgallate |
170172 |
Norma Gill, et. Al. |
“Odor Barriers” |
170179 |
Requa maufacturing Co. Inc. |
Activated Cahrcoal |
170226 |
FDA |
References |
17PPAI |
FDA |
Panel Administrator’s File |
Digestive Aid Drug Products For
Over-the-Counter Human Use
Administrative Record
(Docket No. 81N-0106)
Index to Panel Submissions
Submitted
By |
||
170003 |
Van Patten Pharmaceutical Co. |
Alliman Tablets |
170006 |
Chattem, Inc. |
Cardui Liquid |
170017 |
Requa manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170018 |
Reed & Carnrick Pharmaceuticals |
Phazyme Tablets |
170019 |
Reed & Carnrick Pharmaceuticals |
Phasil Tablets |
170020 |
Reed & Carnrick Pharmaceuticals |
Laxsil Liquid |
170023 |
Winthrop Products Inc. |
Acidol-Pepsin Capsules |
170034 |
Winthrop Products Inc. |
Stamyl Tablets |
170042 |
Purdue Frederick Co. |
ProBilagol Liquid |
170049 |
Dorsey Laboratories |
Kanulase Tablets |
170053 |
Lewis_Howe Company |
Tums and Dicarbosil Tablets |
170054 |
Warner/Chilcott |
Gelusil Tablets and Liquid |
170055 |
Signet Laboratories Inc. |
Dihepatone Tablets |
170058 |
Lewis-Howe Company |
Tums and Dicarbosil Tablets |
170059 |
Warner/Chilcott |
Gelusil Tablets and Liquid |
170061 |
Warner-Lambert Company |
Rolaids Tablets |
170062 |
Requa Manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170063 |
Warner/Chilcott |
Gelusil Tablets and Liquid |
170065 |
Requa Manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170074 |
Warner-Lambert Company |
Bromo-Seltzer Granules |
170075 |
Winthrop Products Inc. |
Stamyl Tablets |
170098 |
Lewis-Howe Company |
Tums ad Dicarbosil tablets |
170100 |
Carter Products |
Gastroenterase Tablets |
170106 |
Winthrop Products Inc. |
Stamyl Tablets |
170120 |
Lewis-Howe Company |
Tums and Dicarbosil Tablets |
170128 |
Warner-Lambert Company |
Hydrate Magnesium Aluminate Activated Sulfate Liquid & Tablets |
170130 |
Parke-Davis & Co. |
Panteric Capsules, Tablets and Granules |
170131 |
Reed & Carnrick Pharmaceuticals |
Phazyme Tablets |
170135 |
Palafox Laboratories, Inc. |
Palagastra Liquid |
170136 |
Reed & Carnrick Pharmaceuticals |
Phazyme Tablets |
170137 |
Warner-Lambert Company |
Rolaids Tablets |
170140 |
Bowman Pharmaceuticals Inc. The Rilox Company Father Francis’ Herbs |
Controflex Phosphorated Syrup Brodie’s Cordial Liquid Medicinal Tea No. 1 & No. 3 |
170142 |
Warner-Lambert Company |
Hydrate Magnesium Aluminate Activated Sulfate Liquid & Tablets |
170143 |
Requa Manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170144 |
Hoechst-Roussel Pharmaceuticals Inc. |
Festal Tablets |
170145 |
Hoechst-Roussel Pharmaceuticals Inc. |
Festal Tablets |
170146 |
Hoechst-Roussel Pharmaceuticals Inc. |
Festal Tablets |
170151 |
Requa Manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170152 |
Requa Manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170154 |
Requa Manufacturing Co., Inc. |
Activated Charcoal Tablets and Capsules, Charcoal Tablets |
170156 |
Warner-Lambert Company |
Roliads Tablets |
170159 |
Reed & Carnrick Pharmaceuticals |
Phazyme Tablets |
170230 |
|
Cited References A – H |
170231 |
|
Cited References J – Z |
170232 |
|
Unicited References |
17GPAI |
|
Panel Administrator’s File (1.1 – 1.6) |
17GPAII |
|
Panel Administrator’s File (Correspondence 1973-1981) |
ORALLY ADMINISTERED DRUG PRODUCTS FOR RELIEF OF SYMPTOMS
ASSOCIATED WITH OVERINDULGENCE IN ALCOHOL AND FOOD
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO. 82N-0166)
INDEX TO PANEL SUBMISSIONS
Submitted
By |
Subject |
|
170015 |
Schmid Laboratories, Inc. |
Fructose tablets |
170016 |
Cary Corporation |
Chaser tablets |
170107 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170108 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170109 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170110 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170111 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170112 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170113 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170114 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170115 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170116 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170117 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170118 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170123 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170132 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170151 |
Requa manufacturing Company, Inc. |
Requa’s Activated Charcoal tablets and capsules |
170175 |
Lemmon Company |
Quick. Over capsules |
170177 |
Warner-Lambert Company |
Bromo-Seltzer granules |
170181 |
Requa Manufacturing Company, Inc. |
Requa’s Activated Charcoal tablets and capsules |
170187 |
|
Pepto-Bismol Liquid |
170188 |
Cary Corporation |
Chaser tablets |
170189 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170190 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170191 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170192 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170193 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170194 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170195 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170196 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170197 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170198 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170199 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170200 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170201 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170202 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170203 |
Miles Laboratories, Inc. |
Alka Seltzer tablets |
170204 |
Miles Laboratories, Inc. |
Alka Seltzer tablets |
170205 |
Miles Laboratories, Inc. |
Alka Seltzer tablets |
170206 |
|
Pepto-Bismol liquid |
170208 |
|
Pepto-Bismol liquid |
170212 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170213 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170214 |
Miles Laboratories, Inc. |
Alka-Seltzer tablets |
170220 |
Schmid Laboratories, Inc. |
Fructose tablets |
170236 |
|
Cited References |
170237 |
|
Uncited References (A through I) |
170238 |
|
Uncited References (J through Y) |
17LPAI |
|
Panel Administrator’s File (Sections 1.1 – 1.6) |
17LPAII |
|
Panel Administrator’s File (Correspondence 1974 through 1981) |
QUININE FOR THE TREATMENT OF NOCTURNAL LEG MUSCLE CRAMPS
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO. 77N-0094) INDEX TO
PANEL SUBMISSIONS
Submitted
By |
||
170050 |
Purex Corporation |
Quinine sulfate capsules |
170234 |
FDA-Generated Material |
Miscellaneous Information |
17QPAI |
|
Panel Administrator’s File |
APHRODISIAC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO. 80N-0419)
INDEX TO PANEL SUBMISSIONS
Submitted
By |
Subject |
|
17JPAI |
|
Panel Administrator’s File |
DRUG PRODUCTS TO TREAT THE SYMPTOMS
ON BENIGN PROSTATIC HYPERTROPHY
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO. 82N-0168)
INDEX TO PANEL SUBMISSIONS
Submitted
By |
Subject |
|
170233 |
FDA-Generated material |
Miscellaneous Information |
17RPAI |
|
Panel Administrator’s File |
Weight control drug products for
Over-the-Counter Human Use
Administrative Record
(Docket No. 81N-0022)
INDEX TO PANEL SUBMISSIONS
Submitted
By |
Subject |
|
170009 |
Thompson Medical Co., Inc. |
Appedrine tablets |
170010 |
Thompson Medical C., Inc. |
Slim-Line candy |
170012 |
Marion Laboratories, Inc. |
Pretts tablets |
170013 |
Thompson Medical Co., Inc. |
Slim-Line candy |
170028 |
Fox Pharmacal, Inc. |
Odrinex tablets |
170029 |
Fox Pharmacal, Inc. |
Odrinex tablets |
170030 |
Thompson Medical Co., Inc. |
Prolamine capsules |
170037 |
Thompson Medical Co., inc. |
Slim-Mint gum |
170041 |
Alleghany Pharmaceutical Corp. |
Hungrex w/P.P.A. tablets |
170044 |
Marion Laboratories, Inc. |
Pretts tablets |
170047 |
Thompson Medical Co., Inc. |
Appedrine tablets |
170048 |
Thompson Medical Co., Inc. |
Slim-Line candy |
170051 |
Marion Laboratories, Inc. |
Pretts tablets |
170056 |
Purex Corp. |
Slendron capsules |
170057 |
Fox Pharmacal, Inc. |
Odrinex tablets |
170060 |
Thompson Medical Co., Inc. |
Appedrine tablets |
170067 |
Thompson Medical Co., Inc. |
Appedrine tablets |
170082 |
Marion Laboratories, Inc. |
Pretts tablets |
170093 |
Thompson Medical Co., Inc. |
Slim-Mint gum |
170094 |
Thompson Medical Co., Inc. |
Slim-Line candy |
170096 |
Thompson Medical Co., Inc. |
Prolamine capsules |
170119 |
Marion Laboratories, Inc. |
Pretts tablets |
170126 |
Thompson Medical Co., Inc. |
Weight Control Information |
170127 |
Thompson MedicalCo., inc. |
Slim-Mint gum and Slin-Line candy |
170141 |
Marion Laboratories, Inc. |
Pretts tablets |
170147 |
Fox Pharmacal, Inc. |
Super-Odrinex tablets |
170148 |
Fox Pharmacal, Inc. |
Super-Odrinex tablets |
170149 |
Fox Pharmacal, Inc. |
Super-Odrinex tablets |
170153 |
Fox Pharmacal, Inc. |
Super-Odrinex tablets |
170155 |
Thompson Medical Co., Inc. |
Phenylpropanolamine |
170164 |
Fox Pharmacal, Inc. |
Super-Odrinex tablets |
170166 |
Alleghany pharmaceutical Corp. |
Permathene-12 capsules |
170235 |
|
Cited and uncited References |
17EPAI |
|
Panel Administrator’s File (1.1 – 1.6) |
17EPAII |
|
Panel Administrator’s File (Correspondence 1975-1977) |
17EPAIII |
|
Panel Administrator’s File (Correspondence 1977-1982) |
ORALLY ADMINISTERED MENSTRUAL DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO. 82N-0165)
Submitted
By |
Subject |
|
170004 |
Whitehall Laboratories, Inc. |
Trendar tablets |
170022 |
Sterling Drug Inc. |
Midol tablets |
170025 |
USV Pharmaceutical Corporation |
Femicin tablets |
170026 |
Chattem, Inc. |
Neo Bromth tablets |
170027 |
Chattem, Inc. |
Pamprin tablets, Cardui tablets, and Zodiex tablets |
170031 |
The Emko Company |
Sunril capsules |
170032 |
Thompson Medical Company, Inc. |
Aqua-Ban tablets |
170046 |
Thompson Medical Company, Inc. |
Aqua-Ban tablets |
170066 |
Pfizer Pharmaceuticals |
Femanol liquid |
170076 |
Cooper Laboratories, Inc. |
Lydia E. Pinkham tablets and Vegetable Compound liquid |
170077 |
Cooper Laboratories, Inc. |
Lydia E. Pinkham tablets and Vegetable Compound liquid |
170078 |
Cooper Laboratories, Inc. |
Lydia E. Pinkham tablets and Vegetable Compound liquid |
170079 |
Cooper Laboratories, Inc. |
Lydia E. Pinkham tablets and Vegetable Compound liquid |
170080 |
Cooper Laboratories, Inc. |
Lydia E. Pinkham tablets and Vegetable compound liquid |
170081 |
Cooper Laboratories, Inc. |
Lydia E. Pinkham tablets and Vegetable Compound liquid |
170095 |
Thompson Medical Company, Inc. |
Aqua-Ben tablets |
170097 |
McNeil Laboatories, inc. |
Tylenol tablets and Tylenol with Codeine tablets |
170121 |
Pfizer pharmaceuticals |
Femanol liquid |
170209 |
Chattem, inc. |
Pamabrom-containing products |
170210 |
Sterling Drug Inc. |
Midol tablets |
170217 |
Thompson Medical Company, Inc. |
Aqua-ban tablets |
170218 |
Chattem, Inc. |
Pyrilamine maleate-menstrual syndrome |
170219 |
Chattem, Inc. |
Pamprin tablets |
170221 |
Chattem, Inc. |
Pamabrom/pyrilamine maleate combinations |
170222 |
|
Midol tablets |
170223 |
Chattem, Inc. |
Pamabrom/pyrilamine maleate combinations |
170224 |
Chattem, Inc. |
Pamprin tablets |
170225 |
Sterling Drug Inc. |
Midol tablets |
170239 |
|
Cited References (A – H) |
170240 |
|
Cited References (I – Y) |
170241 |
|
Uncited References |
17MPAI |
|
Panel Administrator’s File (1.1 – 1.6) |
17MPAII |
|
Panel Administrator’s File (Correspondence) |
NO _______IFM___________ VOLUME WAS MADE FOR ________________________________
CHOLECYSTOKINETIC
DRUG________________________________________________________
TFM VOLUME 17ATFM____________________________
Has been established for STOMACH____________________
ACIDIFIER_______________________________________
_________________________________________________
TFM VOLUME 17FTFM_____________________
Has been established for ANTHELMINTIE_________________
DRUG_PRODUCTS___________________________________
___________________________________________________
TFM VOLUME 17HTFM_________________
Has been established for HYPOPHOSPHATEMIA_____________
AND HYPERPHOSPHATEMIA___________________________
TFM VOLUME 17JTFM___________________
Has been established for
APHRODISIAC__________________________
DRUG PRODUCTS__________________________________________
TFM VOLUME 17OTFM__________________________
Has been established for POISON
TREATMENT_________________________
_________________________________________________________________
Submitted
By |
Trade
Name |
Ingredients |
Remarks |
|
180001 |
FDA |
|
Caffeine |
Literature Search Abstracts |
180002 |
Bristol-Myers |
NO-DOZ |
Caffeine |
“Fast active keep alert Tablets” |
180003 |
J.B. Williams |
Viviran |
Caffeine |
“Stimulant Tablets” |
180004 |
“ |
“ |
“ |
“ “ |
180005 |
“ |
“ |
“ |
“ “ |
180006 |
“ |
“ |
“ |
“ “ |
180007 |
“ |
“ |
“ |
“ “ |
180008 |
Jerrard Cosmetics LTD. |
|
Caffeine |
“Stimulant capsules” “…to enhance your sensual awareness” “…also contains 45 I.V. Vitamin E and 10mg Ginseng” |
180009 |
Blair Labs. Inc. |
Pre-Mens Forte Tablets |
Ammonium Cl Caffeine |
“Helps relieve premenstrual symptoms: swelling weight gain and fatique” |
ADMINISTRATIVE FILE
TOPICAL ANTIBIOTICS
Company |
||
190001 |
Dow Chemical |
Neo-Polycin |
190002 |
Squibb |
Spectrocin Ointment |
190003 |
Upjohn |
Baciguent |
190004 |
Upjohn |
Myciguent |
190005 |
Upjohn |
Mycitracin |
190006 |
Day-Baldwin |
Bacitracin-Neomycin |
190007 |
“ |
Bacitracin |
190008 |
“ |
Neomycin |
190009 |
“ |
“3” Antibiotic |
190010 |
“ |
Bibliography-Antibiotics |
190011 |
Merrell-National |
Bacitracin |
190012 |
Bederle |
Achromycin and Aureomycin |
190013 |
Pfizer |
Bacitracin |
190014 |
Pfizer |
Terramycin |
190015 |
FDA Medical Library |
Abstracts-Bibliography-TA |
190016 |
FDA “ “ |
Bibliography-TA |
190017 |
Burroughs-Wellcome |
Topical Antibiotic Ointments |
190018 |
FDA-Div. Anti-Infective Drugs |
Neosporin Ointment |
190019 |
Industry Task Force |
Topical Antibiotic Products |
190020 |
“ “ “ |
Supporting Reprint A-E |
190021 |
“ “ “ |
“ “ F-K |
190022 |
“ “ “ |
“ “ L-N |
190023 |
“ “ “ |
“ “ O-R |
190024 |
“ “ “ |
“ “ S-Z |
190025 |
Industry Task Force |
Addendum to Safety & Efficacy |
190026 |
Marion Sulzberger |
Neomycin sensitivity |
190027 |
Wm. F. Schorr, M.D. |
Polmycin allergy |
Reference Topical Antibiotic A-D E-G H-J K-L M-Q R-Z |
|
|
Transcript – May 16, 1975
Transcript – June 27, 1975-Scheuplein
Summary Minutes of Panel Meetings
Antimicrobial II – Fungal infections for the Feet
Antimicrobial II – Draft of Panel report (#9 (8-76))