WARNER-LAMBERT LISTERINE ALCOHOL COMMENTS TO OTC FIRST AID ANTISEPTIC
WARNER-LAMBERT LISTERINE ALCOHOL COMMENTS TO OTC FIRST AID ANTISEPTIC tentative final monograph seek to have the Listerine formulation qualify as a topical use antiseptic with four active ingredients, the company explained in a Feb. 25 letter to "The Pink Sheet." In a Jan. 21 letter to the agency, Warner-Lambert sought to clarify the status of 26.9% alcohol as part of the active ingredient list in the Listerine formula as a topical agent. The alcohol content, the company said, does not add to the antimicrobial effect of the other four ingredients and should not be included as an active ingredient in the TFM. The alcohol acts only as a "pharmaceutical necessity to solubilize the active ingredients." The "sole intention" of Warner-Lambert's Jan. 21 submission to FDA "was to clarify the science behind the skin antiseptic activity of the Listerine formula. Specifically, that alcohol does not contribute to the efficacy and therefore should not be included as an active ingredient," the company explained in the letter to "The Pink Sheet." The company further declared that its interest in the First Aid Antiseptic TFM "relates to future topical skin products, not Listerine Antiseptic mouthwash." The TFM, published by FDA in the July 22, 1991 Federal Register, appears unclear in its treatment of the alcohol in the Listerine formula. In the preamble to the monograph, the agency implies that the alcohol may be the vehicle for the other four active ingredients. FDA says that it is listing as Category I a "combination product containing eucalyptol 0.091%, menthol 0.042%, methyl salicylate 0.055%, and thymol 0.063% in 26.9% alcohol" [emphasis added]. In the body of the monograph (at section 333.10), however, the agency lists the combination clearly as a five-ingredient product with the alcohol 26.9% as one of the active ingredients." Listerine has previously been marketed as a remedy for skin abrasions, but Warner-Lambert dropped that claim four years ago in order to emphasize the American Dental Association's seal of acceptance for Listerine's ability to control plaque and gingivitis, which was granted in 1987. The Jan. 21 comments to FDA include results from a recent in- house study conducted by Warner-Lambert to support the company's position that the 26.9% alcohol in Listerine does not add to the formulation's antimicrobial efficacy and that its only purpose is to solubilize the four essential oil active ingredients -- eucalyptol, menthol, methyl salicylate and thymol ("The Pink Sheet" Feb. 24, T&G-1). Warner-Lambert noted that if FDA grants its request to treat the 26.9% alcohol as an inactive ingredient, the company would still be required to list the presence and quantity of alcohol on the label. The story in the Feb. 24 issue of "The Pink Sheet" incorrectly suggested that if the alcohol content was changed to an inactive ingredient, the company could avoid listing the percentage of alcohol on the label. "The law requires that products containing alcohol, whether as an active or inactive ingredient, declare the presence of the alcohol and the quantity on the label," the company observed.
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