Antifungal Drug Products for Over-the-Counter Human Use; External Analgesic Drug Products for Over-the-Counter Human Use; Skin Protectant Drug Products for Over-the-Counter Human Use; and Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Reopening of Administrative Records

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The Food and Drug Administration (FDA) is announcing the reopening of the administrative records for four rulemakings to include safety and effectiveness data on over-the-counter (OTC) vaginal douche drug product ingredients that were previously considered in the advance notice of proposed rulemaking for OTC vaginal drug products. The agency is reopening the following rulemakings for consideration of data on vaginal douche drug products: (1) Antifungal drug products, (2) OTC external analgesic drug products (3) OTC skin protectant drug products and (4) OTC topical antimicrobial drug products. This action is part of the ongoing review of OTC drug products conducted by FDA.