# Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use
> **Food and Drug Administration** · Final rule. · Published 2003-05-07 · Effective 2003-06-06 · 68 FR 24347
## Document
- **Document number:** 03-11285
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 24347
- **CFR reference:** 21 CFR 310
- **Publication date:** 2003-05-07
- **Effective date:** 2003-06-06
- **HHS docket:** Docket No. 02N-0359
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing conditions under which over-the-counter (OTC) ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle are generally recognized as safe and effective and not misbranded. This rule also amends the regulation that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list. This final rule is part of FDA's ongoing review of OTC drug products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/05/07/03-11285/ingrown-toenail-relief-drug-products-for-over-the-counter-human-use)
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