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Listerine, store-brand mouthwashes earn warnings

Executive Summary

FDA warns Johnson & Johnson, CVS and Walgreen that the firms' respective mouthwash products make unapproved drug claims for sodium fluoride. Warning letters sent Sept. 27 say Listerine Total Care Anticavity Mouthwash, CVS Complete Care Anticavity Mouthwash and Walgreen Mouth Rinse Full Action all claim to "fight visible plaque above the gum line," representing an antiplaque/antigingivitis claim not covered by the OTC Anticavity Final Monograph and not under consideration for sodium fluoride in the proposed monograph for Oral Healthcare Products for Antigingivitis/Antiplaque. FDA says the warnings are part of its "effort to curtail an increasing number of Federal Food, Drug and Cosmetic Act violations" by mouthwash marketers
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