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Antiseptic warning letter

This article was originally published in The Rose Sheet

Executive Summary

Share Corp. and Athea Labs cited by FDA for Total Solutions antiseptic and skin protectant claims in a recent warning letter. Following inspections of Share Corp.' s (Minneapolis, Minn.) facilities Feb. 18 and 20, the agency notes the tentative final monograph for OTC antiseptics neither proposes "combining antiseptic cleanser with skin protectants" nor intends the product "remain on the skin without rinsing with water." Product labeling also "fails to differentiate between active and inactive ingredients" and lists a color additive not approved by FDA. Athea previously was informed of some of these deviations in a June 20, 1996 warning letter
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