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InnoTek, Inc.'s BottomBetter

This article was originally published in The Tan Sheet

Executive Summary

Is in compliance with FDA's external analgesic and antifungal products final monographs covering diaper rash treatments. A compliance bulletin issued to FDA's field staff in May listed the Innotek product but did not say whether BottomBetter was in compliance ("The Tan Sheet" June 7, In Brief). The active ingredients of Innotek's product are petrolatum (49%) and lanolin (15.5%) -- neither of which are precluded by FDA's Dec. 18, 1992 rulemaking on diaper rash ingredients.

Is in compliance with FDA's external analgesic and antifungal products final monographs covering diaper rash treatments. A compliance bulletin issued to FDA's field staff in May listed the Innotek product but did not say whether BottomBetter was in compliance ("The Tan Sheet" June 7, In Brief). The active ingredients of Innotek's product are petrolatum (49%) and lanolin (15.5%) -- neither of which are precluded by FDA's Dec. 18, 1992 rulemaking on diaper rash ingredients.

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