Topical Antifungal Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph

Zusammenfassung

The Food and Drug Administration (FDA) is issuing a proposed rule that would amend 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 proposal is part of FDA's ongoing review of OTC drug products.