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This article was originally published in The Tan Sheet

Executive Summary

Bequests six- month extension on implementation of OTC anorectal drug products amendment to have more time "to deplete current inventories of existing labels" for witch hazel products, the company said in an Aug. 15 letter to FDA. In June, FDA amended the final monograph for OTC anorectal drugs to change the name of "Hamamelis water" to "witch hazel" in order to be consistent with changes made in the U.S. Pharmacopeia official compendium ("The Tan Sheet" June 6, In Brief). The company stated that all of its "current labels denote Hamamelis Water followed by Witch Hazel in parenthesis," and requested that the effective date of the regulation be extended from Jan. 1, 1995 to June 3, 1995





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