Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use
other · Food and Drug Administration · Rule · Published 2003-05-07 · Effective 2003-06-06 · 68 FR 24347
Document
Document number
03-11285
Federal Register citation
68 FR 24347
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.