OTC - PANEL SUBMISSIONS - INDICES ONLY

COMMENT FILES FOR PANEL SUBMISSIONS

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

ACTION COMPLETED ON THE COMMENT FILES

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

O-T-C ANTACID DATA SUBMISSIONS

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	Whitehall Labs	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	Winthrop Lab.	Creamalin liquid
22	Winthrop Lab.	Creamalin ESP liquid tablets
23	Winthrop Lab.	Tricreamalata liquid tablets

VOLUME #	COMPANY	PRODUCTS
24	Winthrop Lab.	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 Co.	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	PRODUCT
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	Norwich Pharmacal	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.	Geneva Ointment
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	Oxford Chemicals	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	U.S. Borax	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	PRODUCT
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	Norwich Pharmacal	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.	Geneva Ointment
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	Oxford Chemicals 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	U.S. Borax	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 (IND # 6355)	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	Norwich Pharmacal	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 America	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; University of Sherbrooke Quebec, Canada	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. Ottawa Chemical Div.	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	Winthrop Laboratories	Comments on Proposed Definitions and Guidelines
172	Brown	Fine Organics	TBS Additional Data (Summary)
173	Clear	Fine Organics	TBS Additional Data
174	Blue	Sterling	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 Colorado Med. Center Denver, Colorado	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 Jersey City, NJ 07302	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. Memphis, Tenn.	St. Joseph Aspirin for Children	Aspirin
030002	Plough, Inc.	St. Joseph Aspirin	Aspirin
030003	A.H. Robins Co. Richmond, VA	Arthralgen Tablets	Sallcylamide Acetaminophen
030004	A.H. Robins Co.	Pabalate Tablets	Sodium Sallcylate (PABA) Sodium Aminobenzoate
030005 030006 030007	Warner Lambert Co. Morris Plains, N.Y.	Bromo Seltzer	Acetaminophen Phenacetin Potassium bromide Caffeine Sodium bicarbonate Citric acid
030008 to 030015	Miles Laboratories Inc. Elkhart, Indiana	Alka-Seltzer	Aspirin Mono-calcium phosphate Sodium bicarbonate Citric acid
030016 to 030029	McNeil Laboratories, Inc. Camp Hill Road Fort Washington, PA 19034	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 North Chicago, Ill 60064	Children’s Chewable Tab.	Aluminum Aspirin
030038	Smith Kline & French Lab. 15000 Spring Carden St. Philadelphia, Pa 19101	Ecotrin, enteric coated	Aspirin
030039	The Dow Chemical Co. Research Center P.O. Box 10 Zionsville, Indiana 46077	Tenlap Elixir	Acetaminophen
030040	The Dow Chemical Co.	Phensal Tablets	Aspirin Phenacetin Caffeine
030041	Plough, Inc. Memphis, Texas 38101	Aspergum	Aspirin
030042	Warren-Teed Pharm. Inc. Columbus, Ohio 43215	Magan Tablets	Magnesium Salicylate
030043	Whitehall Laboratories Inc. 685 Thrid Avenue New York, N.Y. 10017	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	Whitehall Labs	Anacin	Aspirin Caffeine
030046	Whitehall Labs	Saloxium Tablet	Salicylsalicylic Acid (Salsalate)
030047	VSV Pharmaceutical Corp. 1 Scarsdalle Road Tuckahoe, New York 10707	Liquiprin Suspension	Acetaminophen
030048	USV	Femicin Tablets	Acetaminophen Saliylamide Caffeine Pyrilamine Maleate Homatropine Methylbromide
030049	USV	Comeback Tablets	Acetaminophen Salicylamide Caffeine
030050	Dorsey Laboratories Box 83288 Lincoln, Nebraska 68501	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	Mead Johnson Research Center Evansville, Indiana 47721	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. Fort Washington, Pa 19034	Ascriptin Tablet	Aspirin Magnesium Hydroxide Aluminum Hydroxide
030060	Monsanto Industrial Chemicals Co. 800 N. Lindbergh Boulevard St. Louis, Missouri 63166	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 Bowman Gray School of Medicine	Headache Powders	Phenacetin Caffeine Citric acid Potassium chloride Lactose Aspirin
030064	Sterling Drug Inc. 90 Park Avenue New York, N.Y. 10016	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	Sterling	Mejoral Cafenol Tablet Cafiaspirina Tablet	Aspirin Caffeine Aspirin Caffeine Aspirin Caffeine
030066	Sterling	Midol	Aspirin Cinnamedrin hydrochloride Caffeine
030067	Sterling	Vanquish	Aspirin Acetaminophen Caffeine Dried Aluminum hydroxide gel Magnesium hydroxide
030068	Sterling	Cope	Aspirin Caffeine Methapyrilene fumarate Magnesium hydroxide Dried Aluminum hydroxide gel
030069 to 030072	Bristol-Myers Products New York, New York	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. Buffalo, New York	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 Para Aminobenzoate 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	Hoover Powders	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	Whitehall Laboratories	Anacin Arthritis Pain Formula (Additional Data Prepared by Clinical Resources, Inc.)
030128	McNeil Laboratories, Inc.	Acetaminophen	Acetaminophen (additional data)
030129	Whitehall Laboratories	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 & Co.	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	Crystal size data on aspirin
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	Whitehall Laboratories	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 Berry Cough Syrup
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.	Robitussin PE Syrup
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	Whitehall Labs. Inc.	Dondrill Anticough Tablets
040120	Whitehall Labs. Inc.	Dristan Capsules
040121	Whitehall Labs. Inc.	Primatene Asthma Tablets (P)
040122	Whitehall Labs. Inc.	Primatene Asthma Tablets (M)
040123	Whitehall Labs. Inc.	Dristan Nasal Mist and Vapor Spray
040124	Whitehall Labs. Inc.	Clear and dry Tablets
040125	Whitehall Labs. Inc.	Dristan Cough Formula Liquid
040126	Whitehall Labs. Inc.	Dristan Decongestant Tablets
040127	Whitehall labs. Inc.	Primetime and Bronitin Mist
040128	Whitehall labs. Inc.	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.	St. Joseph’s Cough Syrup for Children
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 Co.	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), Orange
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 Berry Cough Syrup
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	Whitehall Labs. 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 (Portland Retail Druggist Association)	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	Whitehall Labs. Inc.	Quiet World	Acetaminophen Aspirin Methapyrilene Hcl Scopolamine Hbr.
050006	Whitehall Labs.	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	Whitehall Labs. Division of American Home Products		Diphenhydramine	Additional data
050042	Whitehall Labs. Division of American Home Products		Diphenhydramine	Data requestred by Panel
050043	Sedative Panel Working Papers
050044	Del Labs. Inc. Parmingdale, N.Y.	Placin Calmative Capsules	Paminobenzoic Acid Salicylamide Passiflora (Passion Flower) P.E. Euphorbia P.E.
050045	Johnson & Johnson Co. New Brunswick, N.J.			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	SUBJECT
060001	Texas Pharmacal	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	Texas Phar.	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 US and Comparisons with Skin Cancer Data

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	Whitehall Labs., Inc.	Sperti Healing Ointment
060113	Whitehall Labs., Inc.	Digene Chafing Ointment
060114	Whitehall Labs., Inc.	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	SUBJECT
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	American Academy of Dermatology	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 & Co.	Surfadil
060142	Eli Lilly & Co.	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

Panel Administrator’s File

VOLUME	CONTENTS
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	PRODUCT
160074	Marion Health and Safety, Inc.	Poison Ivy Wash
160103	Unimed, Inc.	Residerm (Poison Ivy Lotion)
160132	Marion Health and Safety, Inc.	Zircreme, Ferric Chloride, Sting-Kill
160152	Marion Health and Safety, Inc.	Poison Ivy Wash

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

Panel Administrator’s File

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	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.	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

Panel Administrator’s File

VOLUME	CONTENTS
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	PRODUCT
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	Del laboratories	Detane
160290	Commerce Drug Co., Inc.	Detane
160388	Del Laboratories	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	CONTENTS
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	MARKETED PRODUCTS /SUBJECT
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 Co.	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	CONTENTS
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	PRODUCT
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

Panel Administrator’s File

VOLUME	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 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	VOLUME NO.
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	U.S. Borax	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	U.S. Borax	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.	Geneva Ointment
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	PRODUCT OR SUBJECT
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	Preston Pharmaceutics	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	Preston Pharmaceutics	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 Co.	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)

General 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 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

References Cited in Report

VOLUME	CONTENTS
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	CONTENTS
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	TRADE NAME/SUBJECT
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	McLeans Toothpaste
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	Barnangan AB	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	McLeans Toothpaste Additional Data
080126	Beecham Products	McLeans Toothpaste 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	McLeans Toothpaste 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	McLeans Toothpaste 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	Barnagen AB	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

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 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	CONTENTS
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 Puerto Rico	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	Marion laboratories, Inc.	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	L.A. Formula	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	Denver chemical Mfg., Co.	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 Salol NF 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 Plantago Seed, NF Mineral Oil, USP Phenolphthalein	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 Karaya NF Pectin NF 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 Puerto Rico	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	Bristol Myers Products	Bran	Bran
090101	Bristol Myers Products	Bran	Pharmacology reports
090102	Bristol Myers Products	Bran	Reprints
090103	Bristol Myers Products	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	Forest Laboratories	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	TRADE NAME/SUBJECT
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	Burton, parsons & Company, Inc.	Adsorbonac 5%
100009	Burton, parsons & Company, Inc.	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. University of Pennsylvania	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. Meridian, Mississippi	Letter to Panel on Stye Ointment
100083	Norwich Pharmacal Co.	Supplemental Information on Ocusol Eye Lotion and Comment on Eye Wash and Eye Lotion
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. Meridian, Mississippi	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

VOLUME	CONTENTS
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

VOLUME	FIRM	PRODUCT OR DATA	PRODUCT LABELED INGREDIANTS
110001	Center for Science in the Public Interest Washington D.C. 20036 FDA FDA	Talc Literature Search DESI publications
110004	Holland Rantos Co., Inc. Trenton, NJ 08854	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. Raritan, NJ 08869	Ortho Gynol Contraceptive Jelly	p-Diisobutylphenoxypoly-ethoxyethanol
110006	Ortho Pharmaceutical Corp. Raritan, NJ 08869	Preceptin Contraceptive Gel	p-Diisobutylphenoxypoly- ethoxyethanol
110007	Ortho Pharmaceutical Corp. Raritan, NJ 08869	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. New York, NY 10019	Immolin Contraceptive Vaginal Cream - Jel	methoxypolyoxyethylene glycol 550 Laurate Nonyl phenoxypolyethoxy ethanol.
110017	Juluis Schmid, Inc. New York, NY 10019	Finesse Contraceptive Creme - gel	methoxypolyoxyethylene glycol 550 Laurate, nonoxynol-9
110018	Juluis Schmid, Inc. New York, NY 10019	Finesse Contraceptive Creme - Gel	Methoxypolyethylene glycol 550 laurate, nonoxynol-9
110020	Juluis Schmid, Inc. New York, NY 10019	Ramses Contraceptive Vaginal Jelly	Dodecaethylene glycol mono-laurate, boric acid, alcohol
110021	Holland Rantoes Co., Inc. Piscataway, NJ 08854	Improved Koromex Contraceptive Jelly	Laureth 10S
110026	Ortho Research Foundation Raritan, NJ 08869	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. Raritan, NJ 08869 “ ” “	Rabbit Model preprint 3 references lists re: spermphsiology and animal models for vaginal contraceptives.
110036	Emko Company St. Louis, MO 63147	Emko contraceptive foam Because contraceptive foam	nonyl phenoxy polyoxyethylene ethanol. Benzethorium chloride “ ” “
110040/41	Ortho Pharmaceutical Corp. Raritan, NJ 08869	Vaginal Contraceptive foaming tablet-safety and effectiveness	Menfegol
110045	Proprietary Assn. Wash., DC. 20006	OTC Labeling Indications
110049	Juliu Schmid, Inc.	Ramses	Dodecaethylene glycol monolaurate
110050	Nova Corp of America Cos Cob, CT 06807	Flavo-Cept. Contraceptive jelly	polyethylene glycol 600 monolaurate (PEG-12 Laurate, Dodecaethylene glycol monolaurate
110052	FDA	Mercury Correspondence
110053	Ortho Research Foundation Raritan, NJ 08869	Selective Bibliography: 1975 Supplement to Volume 110026
110055	The Proprietary Assn. Washington, DC 20006	Comments on the November 1978 “Information Copy” - Panels Tentative Findings
110056	Whitehall Laboratories New York, NY 10017	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 America	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	Whitehall	Preparation H Ointment and Suppositories Volume I
120008	Whitehall	Preparation H Ointment and Suppositories Volume II
120009	Whitehall	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 Winthrop Labs. Div	Pontocaine Cream and Ointment Volume I
120014	Sterling Drug Winthrop Labs. Div.	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	Whitehall	Live Yeast Cell Derivative
120022	Ciba-Geigy	Nupercainal Ointment and Suppositories
120023	Ciba-Geigy	Nupercainal Ointment and Suppositories
120024	Sterling Drug Winthrop Labs. Div.	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	Whitehall	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	Bellwood Pharmaceutical	Hemozone
120054	University of Nebraska Medical Center	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	Whitehall	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	Schuylkill Chemical	Allantoin & Alcloxa
120080	Proprietary Association	Comments on Panel’s Draft Report Released December 1977
120081	Ciba-Geigy	Nupercainal Suppositories
120082	Whitehall	Skin Respiratory Factor
120083	Whitehall	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	Boston University	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	Whitehall	Skin Respiratory Factor Presentation
120093	Whitehall	Skin Respiratory Factor Presentation (References)

Alphabetical Listing of

REFERENCES CITED in Report

VOLUME	CONTENTS
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

PUBLIC ADMINISTRATOR’S FILE

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	TRADE NAME/ SUBJECT
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	Denver Chemical Manufacturing Co.	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	Whitehall Laboratories	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	Norwich Pharmacal	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 Academy of Sciences	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	Marion Laboratories	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	Forsyth Dental Center	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	CONTENTS
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	CONTENTS
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	SUBJECT
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

VOLUME	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	Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal	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 Bristol-	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)

VOLUME	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 Orange Flavored Tablets 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 & E Perles 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 Cocoa Flavor 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 Co.	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	Covington & Burling	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)

Volume	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

Volume No.	Submitted By	Marketed Products/Subject
160021	Pfizer Pharmaceuticals	Desitin Ointment
160025	Corona Manufacturing Co.	Corona Ointment
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.	Corona Ointment
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	University of Pennsylvania	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

Volume No	Submitted By	Product
160074	Manidn Health and Safety, Inc.	Poison Ivy Wash
160103	Unimed, Inc.	Residerm (Poison Ivy Lotion)
160132	Marion Health and Safety, Inc.	Zircreme, Ferric Chloride, Sting Kill
160152	Marion Health and Safety, Inc.	Poison Ivy Wash

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	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

Panel Administrator’s File

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

Panel Administrator’s File

16JPA1

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

Mercury-Containing Drug Products for Topical Antimicrobial OTC Human Use

Index of OTC Volumes

Docket No. 75N-0183

Volume	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 Co.	Thimerosal
160270	Hynson, Westcott & Dunnig, Inc.	Merbromin
160271	Whitehall Laboratories	Phenylmercuric Nitrate
16HPA1-A		Cited References
16HPA1-B		Miscellaneous Uncited References

Administrative File

OTC Mercury-Containing Drug Products for

Topical Antimicrobial Use

Docket No. 75N-0183

Panel Administrator’s File

16HPA1

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)

Volume No.	Submitted By	Products/Subject
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

Public Administrative File

OTC Skin Bleaching Products

Volume	Company	Product
160056	USV Pharmaceutical Corporation Tuckahoe, New York 10707	Esoterica Regular, Esoterica Facial, Esoterica Fortified, Esoterica Lotion, Esoterica Special, Golden Peacock Bleach Cream
160072	Plough, Inc. Memphis, Tenn. 38151	Artra Skin Tone Cream
160081	Chattem Drug & Chemical Co. Chattanooga, Tenn. 37409	Ultra Nadinola Cream, Deluxe Nadinola Complexion Cream, Derma Blanch, Nadinola Double Care Lotion
160112	Nicholas Products Ltd. Waukeska, Wisconsin 53186	Ambi Skin Cream (Vol. I)
160113	Ambi Cosmetics – USA (Animal Safety Data, Part 1)	Hydroquinone (Vol. II)
160114	Ambi Cosmetics – USA (Animal Safety Data, Part 2)	Hydroquinone (Vol. III)
160115	Ambi Cosmetics – USA (Medical rationale)	Ambi skin cream (Vol. VI)
160116	Ambi Cosmetics – USA (Effectiveness data)	Hydroquinone and Glyceryl – PABA (Vol. V)
160117	Ambi Cosmetics – USA (Human safety data)	Hydroquinone and Glyceryl – PABA (Vol. IV)
16A294	Skin Bleaching Products— References

Panel Administrator’s File

16APAI—Panel Administrator’s File Volume I—Skin Bleaching Products

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

Volume	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

Volume	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

Volume	Contents
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

Volume	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 Nebraska Medical Center Carol R. Angle, MD	Camphor
160358	University of Pennsylvania Hospital Harry E. Morton, ScD	Camphor

Administrative File

OTC Camphorated Oil and Camphor-Containing Drug Products

Dockets No 80N-0227

Volume	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

Volume	Submitted By	Subject
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 Edinburgh, Scotland, UK	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

Volume	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

Volume	Submitted By	Subject
160100	Scholl, Inc.	Sodium Sulfide
160127	Whitehall Laboratories	Chlorobutanol, Tannic Acid, Isopropyl Alcohol
160280	Scholl, Inc.	Sodium Sulfide
160384	Whitehall Laboratories	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

Volume	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

Volume	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

Volume	Contents
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

Volume No.	Submitted By	Products/Subject
160003	Whitehall laboratories	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	Whitehall Laboratories	Freezone
160256	Scholl, Inc.	A report on “Outpatient Utilization of ICPM Foot Clinic”
160282A & B	Whitehall Laboratories	Salicylic acid
160283	Whitehall Laboratories	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

Volume	Contents
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)

Volume No.	Submitted By	Products/Subject
160055	Sterling Drug, Inc. New York, NY 10016	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 Tuckahoe, NY 10707	Hormonex Beauty Serum; Hormonex in Cream; Hormonex hair and Scalp Serum
160095	Helena Rubinstein New York, NY 10022	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

Volume	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)

Volume No	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	Fairfield american Corporation	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

Volume	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)

Volume No	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

Volume	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

Volume No	Submitted by	Marketed Products/Subject
160021	Pfizer Pharmaceuticals	Desitin Ointment
160025	Corona Manufacturing Co.	Corona Ointment
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	Corona manufacturing Co.	Corona Ointment
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	University of Pennsylvania	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

Volume	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

Volume No.	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.	Poison Ivy Wash

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	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	Del Laboratories	Detane
160290	Commerce Drug Co., Inc.	Detane
160388	Del Laboratories	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	Contents
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

Volume No.	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 Co.	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

Volume	Contents
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	Product
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

Volume	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

Volume No.	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	Whitehall Laboratories	Oxipor VHC Lotion
160134	Whitehall Laboratories	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	Whitehall Laboratories	Oxipor VHC Lotion
160253	Westwoord Pharmaceuticals, Inc.	Estar Therapeutic Tar Gel
160255	H.B. Distributing Co.	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	Whitehall Laboratories	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 Normal Hair, Selsun Blue for Dry Hair, Selsun Blue for Oily Hair
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 Co.	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	Whitehall Laboratories	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

Volume	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

Volume No.	Firm	Subject
170011	Stuart Pharmaceuticals	Stuart Amino Acids with B12
170023	Winthrop Laboratories	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

Volume No.	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

Volume No.	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)

Volume No.	Submitted By	Subject
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

OTC Vol Number	Submitted By	Subject
170034	Winthrop Labs.	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

OTC Volume Number	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)

OTC Volume Number	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	Subject
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

OTC Volume No.	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

OTC Volume Number	Submitted By	Subject
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

OTC Volume No.	Submitted By	Subject
170014	Rystan Company Inc.	Derifil Tablets Chloresium Tablets Activated Charcoal
170125	Brooklyn-Cumberland Medical Center	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

OTC Volume No.	Submitted By	Subject
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

OTC Volume No.	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	Norwich Eaton Pharmaceuticals	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	Norwich Eaton Pharmaceuticals	Pepto-Bismol liquid
170208	Norwich Eaton Pharmaceuticals	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

OTC Volume No.	Submitted By	Subject
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

OTC Volume No.	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

OTC Volume No.	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

OTC Volume No.	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)

OTC Volume No.	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	Sterling drug inc.	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________________________________________________________

PRODUCTS________________________________________________________________________

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_________________________

_________________________________________________________________

OTC STIMULANT SUBMISSION

Volume No.	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.	Love Garden Stimulant	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

Volume	Company	Subject
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))