Dental Products Panel okays use of Colgate Total in children; requires label disclosure.
This article was originally published in The Rose Sheet
Executive Summary
DENTAL PRODUCTS PANEL OKAYS COLGATE TOTAL USE IN CHILDREN as long as the labeling of the triclosan toothpaste discloses that efficacy in children has not been established. On Feb. 29, FDA's Dental Products Panel and some members of the Dental Drug Products Plaque Subcommittee reviewed Colgate-Palmolive's NDA for its Total toothpaste and cleared the anti- plaque, antigingivitis and anticaries dentifrice containing triclosan .3% and sodium fluoride .24% for approval (The Rose Sheet" March 4, p. 5).