Drugs

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking8/4/197843FR34628
        Correction9/19/197843FR42018
Reopening of Administrative Record3/21/198045FR18402
Proposed RuleDateFR Citation
Tentative Final Monograph2/15/198348FR6820
Correction4/12/198348FR15655
Reopening of Administrative Record: To include "hard fat"12/19/199156FR65873
Final RuleDateFR Citation
Final Monograph6/4/200368FR33362
Technical Amendment: Corrects indications12/9/200368FR68509
Technical Amendment: Corrects "approved as of date" in 21 CFR 310.5458/19/200469FR51362
Technical Amendment: Lip protectant labeling2/1/200873FR6014
Availability of Guidance (Labeling)8/4/200873FR45227

Skin Protectant Drug Products: Astringent

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking9/7/198247FR39436
Correction10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule4/3/198954FR13490
Correction4/27/198954FR18197
Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph6/13/200368FR35346
Final RuleDateFR Citation
Final Rule10/21/199358FR54458
Final Rule: Revises "Hamamelis water" to "witch hazel"6/3/199459FR28767
Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph6/13/200368FR35290
Confirmation of effective date10/9/200368FR58273
Correction1/22/200469FR3005
Technical Amendment: Astringents producing aluminum acetate3/6/200974FR9759

Skin Protectant Drug Products: Diaper Rash

Advance Notice Of Proposed RulemakingDateFRCitation
Reopening of Administrative Record9/7/198247FR39436
    Correction10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule6/20/199055FR25204
    Extension of Comment Period: Vitamins A and D12/18/199055FR51926
Final RuleDateFR Citation
Final Monograph6/4/200368FR33362
        Technical Amendment: Corrects indications12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.5458/19/200469FR51362

Skin Protectant Drug Products: Fever Blister and Cold Sore

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record9/7/198247FR39436
        Correction10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule: Skin Protectants; External Analgesics for Fever Blister and Cold Sore Treatment1/31/199055FR3362
        Correction3/27/199055FR11291
Final RuleDateFR Citation
Final Monograph6/4/200368FR33362
        Technical Amendment: Corrects indications12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.5458/19/200469FR51362

Skin Protectant Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568
    Correction9/8/199257FR40944
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
    Correction11/9/199257FR53300
Proposed Rule: 60+ Drug Categories6/19/200873FR34895
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636

Skin Protectant Drug Products: Poison Ivy, Oak, Sumac and Insect Bites

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record9/7/198247FR39436
        Correction10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule

10/3/1989

55FR40808
Final RuleDateFR Citation
Final Monograph6/4/200368FR33362
        Technical Amendment: Corrects indications12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.5458/19/200469FR51362

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Page Last Updated: 05/04/2017
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