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Isopropyl alcohol/glycerin to be added to monograph for water-clogged ears -- FDA tells Del.

This article was originally published in The Tan Sheet

Executive Summary

OTIC DRUGS MONOGRAPH: 95% ISOPROPYL ALCOHOL/5% GLYCERIN TO BE ADDED to the monograph for "drying water-clogged ears," FDA notified the Washington, D.C. law firm of Buc Levitt & Beardsley on June 22. Responding to a citizen petition filed by the firm on behalf of Del Pharmaceuticals, FDA said it intends to include 95% isopropyl alcohol in 5% glycerin in the OTC topical otic drugs monograph under the indication: "For drying water-clogged ears," or "Dries and relieves water-clogged ears due to swimming, diving, surfing or showering." Del makes the Auro-Dri brand of isopropyl alcohol/glycerin.

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