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  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Skin Protectant Drug Products
  1. Status of OTC Rulemakings

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:

  • Original Active Ingredients and Labeling
  • Astringent
  • Diaper Rash
  • Fever Blister and Cold Sore
  • Nonnonograph Ingredients
  • Poison Ivy, Oak, Sumac and Insect Bites

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 48FR6820
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
Technical Amendment: Astringents producing aluminum acetate 3/6/2009 74FR9759

Skin Protectant Drug Products: Diaper Rash

Advance Notice Of Proposed Rulemaking Date FRCitation
Reopening of Administrative Record 9/7/1982 47FR39436
    Correction 10/15/1982 47FR46117
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 47FR46117
Proposed Rule Date FR Citation
Proposed Rule: Skin Protectants; External Analgesics for Fever Blister and Cold Sore Treatment 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 47FR46117
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

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