Topical Otic Drug Products for Over-the-Counter Human Use; Products for Drying Water-Clogged Ears; Amendment of Monograph; Lift of Partial Stay of Effective Date

The Food and Drug Administration (FDA) is issuing a final rule amending the 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 adds conditions for marketing topical otic drug products for drying water-clogged ears and includes labeling in the new OTC drug format. The agency is amending its final regulations for OTC drug labeling requirements to include the new flammability warning for topical otic drug products for drying water-clogged ears. The agency is also lifting a partial stay of the effective date of certain provisions of the regulations for topical otic drug products for the drying of water clogged ears. This final rule is part of the ongoing review of OTC drug products conducted by FDA.