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In Brief: FDA on glycerin

This article was originally published in The Tan 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 letter reviewing a study submitted by the firm. The study compared groups of subjects who used Cornhuskers hand lotion formulas containing .2% allantoin and either 2%, 10% or 18% glycerin to 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'" outlined in the TFM for 20-45% glycerin products...

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