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In Brief: FDA on glycerin

This article was originally published in The Rose Sheet

Executive Summary

FDA on glycerin: The agency does not plan to include glycerin at concentrations less than 20% in the final monograph for OTC skin protectants, FDA tells Warner-Lambert in an Aug. 23 response to a study submitted by the firm. The study compares groups of subjects who used hand lotions containing .2 allantoin and either 2%, 10% or 18% glycerin with a no-treatment control group. FDA determined that the study "fails to demonstrate that 2%, 10% or 18% glycerin is effective for the indication `helps prevent and temporarily protects chafed, chapped, cracked, or windburned skin and lips'" -- the indication for hand lotions with 20-45% glycerin in the tentative final monograph...
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