In Brief: Eugenol for toothache
This article was originally published in The Tan Sheet
Executive Summary
Eugenol for toothache: OTC "feedback" meeting between FDA and representatives of The Mentholatum Company is scheduled for Sept. 8 to discuss the revised protocol for a study submitted by the firm in February for the efficacy of eugenol in toothache pain resulting from an open cavity ("The Tan Sheet" March 3, In Brief). The ingredient, contained in Mentholatum's Red Cross Toothache First Aid Medication, was classified as Category III (data are insufficient) in the 1991 tentative final monograph for oral discomfort products. The meeting will start at 1:30 p.m. in Suite 200 at FDA's 9201 Corporate Blvd. building, Rockville, Md...