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OTC fluoride treatment rinses, gels should carry poison warnings on labels -- FDA's Bowen.

This article was originally published in The Rose Sheet

Executive Summary

OTC FLUORIDE TREATMENT RINSES, GELS SHOULD CARRY POISON WARNINGS ON LABELS, FDA OTC Division Director Debra Bowen, MD, said in a June 14 letter to the Nonprescription Drug Manufacturers Association. Responding to a joint request from NDMA and the Cosmetic, Toiletry, and Fragrance Association for an exemption from the warnings for OTC fluoride-containing preventive treatment gels and treatment rinses, Bowen said the division "has determined that the first and second general warnings under Sec. 330.1(g) should be required in the labeling."

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