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Benzocaine, eugenol stratified clinical trial for oral toothache pain suggested by FDA.

This article was originally published in The Tan Sheet

Executive Summary

OTC TOOTHACHE RELIEF STRATIFIED CLINICAL TRIAL for the ingredients benzocaine and eugenol suggested by OTC Drug Products Medical Reviewer Rosemarie Neuner, MD, at a "feedback" meeting on OTC toothache pain relief products in Rockville, Md. June 25. The agency's suggestion for a stratified trial, which would separate out patients who had ingested an internal analgesic or alcohol prior to receiving an oral toothache treatment, came in response to Mentholatum's inability to enroll patients for a protocol FDA suggested in September 1997.

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