"Ear Drying Aids" Monograph Status Proposed By FDA
This article was originally published in The Tan Sheet
Executive Summary
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.