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U.S. Department of Health and Human Services

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Rulemaking History for OTC Skin Protectant Drug Products

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:


Skin Protectant Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 8/4/1978 43FR34628
        Correction [PDF] 9/19/1978 43FR42018
Reopening of Administrative Record [PDF] 3/21/1980 45FR18402
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 2/15/1983 48FR6820
        Correction [PDF] 4/12/1983 48FR15655
Reopening of Administrative Record: To include "hard fat" [PDF] 12/19/1991 56FR65873
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/2003 68FR33362
        Technical Amendment: Corrects indications [PDF] 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] 8/19/2004 69FR51362
       Technical Amendment: Lip protectant labeling [PDF] 2/1/2008 73FR6014
Availability of Guidance (Labeling) [PDF] 8/4/2008 73FR45227

Skin Protectant Drug Products: Astringent
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/7/1982 47FR39436
        Correction [PDF] 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule [PDF] 4/3/1989 54FR13490
        Correction [PDF] 4/27/1989 54FR18197
Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph [PDF] 6/13/2003 68FR35346
Final Rule Date FR Citation
Final Rule [PDF] 10/21/1993 58FR54458
Final Rule: Revises "Hamamelis water" to "witch hazel" [PDF] 6/3/1994 59FR28767
Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph [PDF] 6/13/2003 68FR35290
        Confirmation of effective date [PDF] 10/9/2003 68FR58273
        Correction [PDF] 1/22/2004 69FR3005
Technical Amendment: Astringents producing aluminum acetate 3/6/2009 74FR9759

Skin Protectant Drug Products: Diaper Rash
Advance Notice Of Proposed Rulemaking Date FR Citation
Reopening of Administrative Record [PDF] 9/7/1982 47FR39436
    Correction [PDF] 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule [PDF] 6/20/1990 55FR25204
    Extension of Comment Period: Vitamins A and D [PDF] 12/18/1990 55FR51926
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/2003 68FR33362
        Technical Amendment: Corrects indications [PDF] 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] 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 [PDF] 9/7/1982 47FR39436
        Correction [PDF] 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule [PDF] 1/31/1990 55FR3362
        Correction [PDF] 3/27/1990 55FR11291
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/2003 68FR33362
        Technical Amendment: Corrects indications [PDF] 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] 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 [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Proposed Rule: 60+ Drug Categories [PDF] 6/19/2008 73FR34895
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 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 [PDF] 9/7/1982 47FR39436
        Correction [PDF] 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule [PDF]

10/3/1989

55FR40808
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/2003 68FR33362
        Technical Amendment: Corrects indications [PDF] 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] 8/19/2004 69FR51362