PERUVIAN BALSAM 6% FOR DIAPER RASH: ADDITIONAL SAFETY DATA NEEDED
This article was originally published in The Tan Sheet
Executive Summary
PERUVIAN BALSAM 6% FOR DIAPER RASH: ADDITIONAL SAFETY DATA NEEDED to demonstrate that the ingredient "is safe for external use in the diaper area of infants," FDA told Charleston, S.C.- based Flanders, Inc. in a recent letter. The letter was in response to several submissions made to the agency by Flanders in support of the safety and efficacy of Peruvian Balsam to treat diaper rash. Peruvian Balsam is the active ingredient in Flanders Buttocks Ointment, the firm's only product.