Food and Drug Administration

Nonprescription Drugs Advisory Committee

and the

Dermatologic and Ophthalmic Drugs Advisory Committee

May 6-7, 2004

Briefing Information

Table of Contents (HTM) (PDF) (Word)

Bibliography (HTM) (PDF) (Word)

Executive Summary (HTM) (PDF) (Word)

Natural History of Tinea Pedis (HTM) (PDF) (Word)

Study Design and Efficacy Results for Tinea Pedis Clinical Trials (HTM) (PDF) (Word)

History and Overview of OTC Monograph for Topical Antifungal Drug Products (HTM) (PDF) (Word)

Federal Register §333.210 Subpart C - Topical Antifungal Drug Products (PDF)

Comparison of Labeling for All Topical Antifungals Treating Athlet's Foot (HTM) (PDF) (Word)

Adverse Events Reports (HTM) (PDF) (Word)

Additional References (HTM) (PDF) (Word)