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Bonne Bell Ten-0-Six label claims, GMP violations subject of FDA warning letter.

This article was originally published in The Rose Sheet

Executive Summary

BONNE BELL TEN-0-SIX ANTIBACTERIAL, ANTI-ACNE CLAIMS QUESTIONED BY FDA in an October 12 warning letter to the Lakewood, OH-based firm. The FDA letter states that labeling for the company's Ten-0-Six Medicated Deep Pore Cleanser, Ten-0-Six Deep Cleansing Antiseptic and Ten-0-Six Deep Cleansing Astringent include claims that suggest the products are "effective in the treatment or prevention of acne and/or provide an antimicrobial effect on the skin" and are therefore considered drugs and subject to FDA regulations regarding such claims.
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