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.