Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
other · Food and Drug Administration · Rule · Published 2002-02-08 · Effective 2002-03-11 · 67 FR 5942
Document
Document number
02-3079
Federal Register citation
67 FR 5942
CFR reference
21 CFR 333
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-02-08
Effective date
2002-03-11
HHS docket
Docket No. 99N-4063
Abstract
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) topical antifungal drug products to add the ingredient clotrimazole as generally recognized as safe and effective for the treatment of athlete's foot, jock itch, and ringworm. This final rule is part of FDA's ongoing review of OTC drug products.