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:


Skin Protectant Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]8/4/197843FR34628
        Correction [PDF]9/19/197843FR42018
Reopening of Administrative Record [PDF]3/21/198045FR18402
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]2/15/198348FR6820
        Correction [PDF]4/12/198348FR15655
Reopening of Administrative Record: To include "hard fat" [PDF]12/19/199156FR65873
Final RuleDateFR Citation
Final Monograph [PDF]6/4/200368FR33362
        Technical Amendment: Corrects indications [PDF]12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF]8/19/200469FR51362
       Technical Amendment: Lip protectant labeling [PDF]2/1/200873FR6014
Availability of Guidance (Labeling) [PDF]8/4/200873FR45227

Skin Protectant Drug Products: Astringent
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/7/198247FR39436
        Correction [PDF]10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule [PDF]4/3/198954FR13490
        Correction [PDF]4/27/198954FR18197
Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph [PDF]6/13/200368FR35346
Final RuleDateFR Citation
Final Rule [PDF]10/21/199358FR54458
Final Rule: Revises "Hamamelis water" to "witch hazel" [PDF]6/3/199459FR28767
Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph [PDF]6/13/200368FR35290
        Confirmation of effective date [PDF]10/9/200368FR58273
        Correction [PDF]1/22/200469FR3005
Technical Amendment: Astringents producing aluminum acetate3/6/200974FR9759

Skin Protectant Drug Products: Diaper Rash
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]9/7/198247FR39436
    Correction [PDF]10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule [PDF]6/20/199055FR25204
    Extension of Comment Period: Vitamins A and D [PDF]12/18/199055FR51926
Final RuleDateFR Citation
Final Monograph [PDF]6/4/200368FR33362
        Technical Amendment: Corrects indications [PDF]12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF]8/19/200469FR51362

Skin Protectant Drug Products: Fever Blister and Cold Sore
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]9/7/198247FR39436
        Correction [PDF]10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule: Skin Protectants; External Analgesics for Fever Blister and Cold Sore Treatment [PDF]1/31/199055FR3362
        Correction [PDF]3/27/199055FR11291
Final RuleDateFR Citation
Final Monograph [PDF]6/4/200368FR33362
        Technical Amendment: Corrects indications [PDF]12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF]8/19/200469FR51362

Skin Protectant Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]8/25/199257FR38568
    Correction [PDF]9/8/199257FR40944
    Technical Amendment: Correct an ingredient name [PDF]10/1/199257FR45295
    Correction [PDF]11/9/199257FR53300
Proposed Rule: 60+ Drug Categories [PDF]6/19/200873FR34895
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/10/199358FR27636

Skin Protectant Drug Products: Poison Ivy, Oak, Sumac and Insect Bites
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]9/7/198247FR39436
        Correction [PDF]10/15/198247FR46117
Proposed RuleDateFR Citation
Proposed Rule [PDF]

10/3/1989

55FR40808
Final RuleDateFR Citation
Final Monograph [PDF]6/4/200368FR33362
        Technical Amendment: Corrects indications [PDF]12/9/200368FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF]8/19/200469FR51362

 

Page Last Updated: 11/19/2014
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