Antiseptic warning letter
This article was originally published in The Tan Sheet
Share Corp. and Athea Labs cited for Total Solutions antiseptic and skin protectant claims in a recent FDA warning letter. Following February inspections of Share's Minneapolis facilities, FDA 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." Labeling "fails to differentiate between active and inactive ingredients" and lists active ingredients and a color additive not approved by FDA, the agency says
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