Blistex

Executive Summary

Will halt clinical efficacy trials of dimethicone and allantoin and their combination for fever blister/cold sore treatment, company told FDA in July 5 letter. Blistex says a May 25 letter to FDA ("The Pink Sheet" June 11, "In Brief") announcing clinical trials was the "result of confusion" about the Jan. 31 fever blister/cold sore amendments to the TFM for OTC skin protectants. Dimethicone and allantoin and their combo are Category I for that indication under the TFM amendments ("The Pink Sheet" Feb. 5, p. 19).