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:
- GPO Federal Register Database (1994 to present)
- HeinOnline
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provides online access to Federal Registers from 1936-forward
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 |