Topical Otic Drug Products for Over-the-Counter Human Use; Products for Drying Water-Clogged Ears; Proposed Amendment of Monograph

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The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would amend the final monograph for over-the- counter (OTC) topical otic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). The amendment would add conditions for marketing topical otic drug products for drying water-clogged ears. Concurrently, the agency is proposing to remove water-clogged ears from one part of the regulation that lists conditions that are not generally recognized as safe and effective and that are misbranded. This proposal contains labeling in the new OTC drug format and is part of the ongoing review of OTC drug products conducted by FDA.