OTC fluoride treatment rinses, gels should carry poison warnings on labels -- FDA's Bowen.
This article was originally published in The Rose Sheet
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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