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Warning letter

This article was originally published in The Tan Sheet

Executive Summary

Tend Skin Intl.' s OTC dermatological products are misbranded, FDA says in recent warning letter. Four products - Tend Skin, Soft Cell, Hard Top and Air Shave Gel - contain ingredients that do not comply with applicable OTC monographs and final rules. Acetylsalicylate-containing Tend Skin, labeled for razor burns and ingrown hair, also carries claims for acne, cold sores, athletes foot, warts and ringworm, agency says. Acetylsalicylate (aspirin) is not recognized as a safe/effective ingredient under the external analgesic monograph. Production methods at firm's Davie, Fla. facility fail to meet GMP regs, letter notes
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