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OTC teeth whiteners

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Executive Summary

"Are unapproved new drugs," FDA tells six manufacturers in recent warning letters. Center for Drug Evaluation and Research Compliance Office Director Dan Michels sent warning letters on Sept. 4 to the marketers of EpiSmile, Instant White and Omni White & Bright, and another three letters on Sept. 9 to the manufacturers of Rembrandt Lighten; Instant White, Dental White, Ultimate White and Dazzle; and Dentlbright. The products, which bear claims for the bleaching of teeth, include ingredients such as calcium peroxide, hydrogen peroxide, carbamide peroxide and perhydrol urea. . . .

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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