PERUVIAN BALSAM USP STANDARDS MUST BE DEVELOPED
This article was originally published in The Tan Sheet
Executive Summary
PERUVIAN BALSAM USP STANDARDS MUST BE DEVELOPED "before the ingredient can be included in the [FDA] final monograph" for OTC diaper rash products, FDA told Charleston, S.C.-based Flanders, Inc. in a recent letter. The company markets Flanders Buttocks Ointment, with 6% Peruvian Balsam. The agency noted that although the ingredient used by the company is "consistent with the [U.S. Pharmacopeial] monograph in the thirteenth (1970) edition of the National Formulary...it will still be necessary that appropriate current standards for quality and purity be developed" with the USP. Peruvian Balsam is not listed in the 1995 USP.
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