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OTC drug labeling format

This article was originally published in The Rose Sheet

Executive Summary

Use of a two-column format in the "Warnings" section of OTC labeling would allow for more information in the "Drug Facts" section and may help solve some of the space problems created by FDA's final rule, the Consumer Healthcare Products Association says in a May 6 letter to the agency. "The use of columns is a significant space saver" and "definitely allows the standard format and the modified format to be used for more SKUs, thereby helping to limit the number of potential exemptions," CHPA says. The letter follows an April 23 "feedback" meeting ("The Rose Sheet" May 3, pp. 8-9). CHPA says it will provide the agency with a more detailed submission but requests a quick turnaround response. The Cosmetic, Toiletry and Fragrance Association is preparing separate comments

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