Colgate Total plaque, gingivitis claims evolution detailed in FDA review documents.
This article was originally published in The Tan Sheet
Executive Summary
COLGATE TOTAL CLAIMS EVOLUTION DETAILED IN FDA REVIEW DOCUMENTS recently made available by the agency for the .3% triclosan/.24% sodium fluoride OTC toothpaste. Colgate Total was approved July 11, 1997 as the first OTC dentifrice allowed to claim efficacy in the prevention of gingivitis, in addition to plaque, tartar, cavities and bad breath ("The Tan Sheet" July 21, 1997, p. 1). The company submitted NDA 20-231 to the agency Dec. 29, 1992, and it was reviewed by FDA's Division of Dermatologic & Dental Drug Products.