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Warner-Lambert conducting clinicals for antigingivitis toothpaste.

This article was originally published in The Rose Sheet

Executive Summary

WARNER-LAMBERT LISTERINE TOOTHPASTE ANTIPLAQUE/ANTIGINGIVITIS INDICATIONS would require a six-month study in humans, FDA's Nonprescription Drugs Advisory Committee's Dental Plaque Subcommittee concluded following a Warner-Lambert presentation on a proposed testing protocol. Based on the subcommittee's prior conclusion that Listerine Antiseptic Mouthwash's essential oil combination -- menthol, thymol, methyl salicylate and eucalyptol -- is a safe and effective antiplaque and antigingivitis agent in concentrations of 51.7 mg/dose ("The Rose Sheet" Nov. 3, 1997, p. 16), the NDAC group determined at its May 27 meeting that one additional trial in humans would be sufficient to establish the ingredient combination's safety and efficacy in a new toothpaste dosage form.
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