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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Ingrown Toenail Drug Products
  1. Historical Status of OTC Rulemakings

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

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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

 

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