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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Ingrown Toenail Drug Products

Final Monograph (21 CFR part 538 subpart D):
Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief 

OTC Ingrown Toenail Drug Products found on this page:


Ingrown Toenail Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 10/17/1980 45FR69128
    Correction [PDF] 12/23/1980 45FR84836
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 9/3/1982 47FR39120
    Correction [PDF] 11/19/1982 47FR52200
Final Rule Date FR Citation
Final Monograph: No GRASE active ingredients [PDF] 9/9/1993 58FR47602

Ingrown Toenail 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
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

Ingrown Toenail Drug Products: Sodium Sulfide
Proposed Rule Date FR Citation
Proposed Rule: Allows 1% sodium sulfide gel [PDF] 10/4/2002 67FR62218
Final Rule Date FR Citation
Final Rule: Allows 1% sodium sulfide gel [PDF] 5/7/2003 68FR24347
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