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Antiseptic handwash directions for use should not be specified in monograph -- comments.

This article was originally published in The Tan Sheet

Executive Summary

ANTISEPTIC HANDWASH DIRECTIONS FOR USE: MANUFACTURER "KNOWS BEST," Bethesda, Md.-based AAC Consulting Group asserted in Jan. 10 comments to FDA on behalf of an unnamed client. The comments recommend that the directions for use specified in the tentative final monograph for OTC topical antimicrobial drug products be changed to read simply: "Follow manufacturer's instructions for applying the sanitizing products to the hands." The TFM as written "favors products designed to be rubbed in the hands," the comments state. The proposed monograph was published in June 1994 ("The Tan Sheet" June 27, 1994, pp. 7-10).
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