Drugs

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

FDA Archive-It webpage:

Search for Federal Register documents:

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 10/17/1980 45FR69128
   Correction 12/23/1980 45FR84836
Proposed Rule Date FR Citation
Tentative Final Monograph 9/3/1982 47FR39120
   Correction 11/19/1982 47FR52200
Final Rule Date FR Citation
Final Monograph: No GRASE active ingredients 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 5/16/1990 55FR20434
   Correction 6/7/1990 55FR23235
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

Ingrown Toenail Drug Products: Sodium Sulfide

Proposed Rule Date FR Citation
Proposed Rule: Allows 1% sodium sulfide gel 10/4/2002 67FR62218
Final Rule Date FR Citation
Final Rule: Allows 1% sodium sulfide gel 5/7/2003 68FR24347

 

Page Last Updated: 12/05/2016
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