Executive Summary

CAMPHOR/MENTHOL TOPICAL/INHALANT PRODUCTS REVISED BURN WARNING concerning the dangers of using the OTC antitussives near an open flame, in hot water or in a microwave oven are proposed by FDA as an amendment to the 1987 final monograph in a notice slated for publication in the July 20 Federal Register. The agency is basing the need for the revised warning on 34 reports of fire-related events between 1983 and mid-1997 that led to burns caused by flashing from the use of antitussives formulated with camphor and/or menthol. FDA is seeking comments on the proposal up to 90 days post-publication and estimates a 12-month implementation for the changes.