In Brief: Pharmakon Labs

Executive Summary

Pharmakon Labs: Orasept oral anesthetic, antiseptic and astringent contains tannic acid, which is not GRAS/E as a cold sore and fever blister treatment ingredient, rendering the product mislabeled, FDA told the firm in a recent warning letter. However, "even without the presence of tannic acid in the formulation for Orasept, the product is a `new drug' because of claims for gingivitis and herpes simplex cold sores found in the labeling" and is misbranded because it fails to bear adequate directions for use, the agency notes...