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  7. Rulemaking History for OTC Ingrown Toenail Drug Products
  1. 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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/17/198045FR69128
   Correction12/23/198045FR84836
Proposed RuleDateFR Citation
Tentative Final Monograph9/3/198247FR39120
   Correction11/19/198247FR52200
Final RuleDateFR Citation
Final Monograph: No GRASE active ingredients9/9/199358FR47602

Ingrown Toenail Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
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

Ingrown Toenail Drug Products: Sodium Sulfide

Proposed RuleDateFR Citation
Proposed Rule: Allows 1% sodium sulfide gel10/4/200267FR62218
Final RuleDateFR Citation
Final Rule: Allows 1% sodium sulfide gel5/7/200368FR24347