Rulemaking History for OTC Skin Protectant Drug Products

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Rulemaking History for OTC Skin Protectant Drug Products
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Final Monograph (21 CFR part 347):
Skin Protectant Drug Products for Over-the-Counter Human Use

OTC Skin Protectant Drug Products found on this page:

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**Skin Protectant Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	8/4/1978	43FR34628
Correction	9/19/1978	43FR42018
Reopening of Administrative Record	3/21/1980	45FR18402
Proposed Rule	Date	FR Citation
Tentative Final Monograph	2/15/1983	45FR18402
Correction	4/12/1983	48FR15655
Reopening of Administrative Record: To include "hard fat"	12/19/1991	56FR65873
Final Rule	Date	FR Citation
Final Monograph	6/4/2003	68FR33362
Technical Amendment: Corrects indications	12/9/2003	68FR68509
Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545	8/19/2004	69FR51362
Technical Amendment: Lip protectant labeling	2/1/2008	73FR6014
Availability of Guidance (Labeling)	8/4/2008	73FR45227

**Skin Protectant Drug Products: Astringent**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/7/1982	47FR39436
Correction	10/15/1982	47FR46117
Proposed Rule	Date	FR Citation
Proposed Rule	4/3/1989	54FR13490
Correction	4/27/1989	54FR18197
Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph	6/13/2003	68FR35346
Final Rule	Date	FR Citation
Final Rule	10/21/1993	58FR54458
Final Rule: Revises "Hamamelis water" to "witch hazel"	6/3/1994	59FR28767
Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph	6/13/2003	68FR35290
Confirmation of effective date	10/9/2003	68FR58273
Correction	1/22/2004	69FR3005

**Skin Protectant Drug Products: Diaper Rash**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	9/7/1982	47FR39436
Correction	10/15/1982	48FR46117
Proposed Rule	Date	FR Citation
Proposed Rule	6/20/1990	55FR25204
Extension of Comment Period: Vitamins A and D	12/18/1990	55FR51926
Final Rule	Date	FR Citation
Final Monograph	6/4/2003	68FR33362
Technical Amendment: Corrects indications	12/9/2003	68FR68509
Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545	8/19/2004	69FR51362

**Skin Protectant Drug Products: Fever Blister and Cold Sore**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	9/7/1982	47FR39436
Correction	10/15/1982	48FR46117
Proposed Rule	Date	FR Citation
Proposed Rule	1/31/1990	55FR3362
Correction	3/27/1990	55FR11291
Final Rule	Date	FR Citation
Final Monograph	6/4/2003	68FR33362
Technical Amendment: Corrects indications	12/9/2003	68FR68509
Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545	8/19/2004	69FR51362

**Skin Protectant Drug Products: Nonmonograph Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	8/25/1992	57FR38568
Correction	9/8/1992	57FR40944
Technical Amendment: Correct an ingredient name	10/1/1992	57FR45295
Correction	11/9/1992	57FR53300
Proposed Rule: 60+ Drug Categories	6/19/2008	73FR34895
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph	5/10/1993	58FR27636

**Skin Protectant Drug Products: Poison Ivy, Oak, Sumac and Insect Bites**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	9/7/1982	47FR39436
Correction	10/15/1982	48FR46117
Proposed Rule	Date	FR Citation
Proposed Rule	10/3/1989	55FR40808
Final Rule	Date	FR Citation
Final Monograph	6/4/2003	68FR33362
Technical Amendment: Corrects indications	12/9/2003	68FR68509
Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545	8/19/2004	69FR51362

Date updated: December 28, 2006;Last updated: August 5, 2008