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Otic Drug Monograph Modified To Include Flammability Warning

This article was originally published in The Tan Sheet

Executive Summary

FDA is amending the final monograph for topical otic drugs to require that labeling of OTC products for drying water-clogged ears contain a flammability warning. The agency also has established mandatory directions and warnings that must appear in the labeling of ear drying aids.

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"Ear Drying Aids" Monograph Status Proposed By FDA

FDA is proposing to amend the topical otic drug products final monograph to include "ear drying aid" products with the active ingredient 95% isopropyl alcohol in a 5% anhydrous glycerin base, the agency announces in the Aug. 17 Federal Register. Such products currently are being marketed under a partial stay of a final rule classifying otic products as not generally recognized as safe and effective for OTC use.

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