Plans to submit clinical evidence demonstrating the efficacy of allantoin and dimethicone for fever blister/cold sore treatment, the company told FDA in a May 25 letter. Blistex is seeking inclusion of the ingredients as Category I for treatment of fever blisters and cold sores in the TFM for OTC skin protectants. Allantoin and dimethicone are listed as Category I skin protectants in the TFM, which was published in the Jan. 31 Federal Register ("The Pink Sheet" Feb. 5, p. 19). New data must be submitted by Jan. 21, 1991.
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