Human drugs.

12907W

Andersen Pharmaceuticals, Norwich, NY, March 4 (New York). The manufacturing facility was inspected Sept. 24-30, 2003, by FDA Investigators Steven Libal and Andrew Abramowitz. During the inspection, the investigators determined that the product Liquid Styptic is misbranded because it is an unapproved new drug. Statements appearing on the immediate container label, such as "Liquid Styptic," "To Stop Bleeding Dab-On Minor Cuts and Manicure Nicks" and "Antiseptic," would indicate that the product is a drug, the warning letter stated. Moreover, because the product is intended to stop bleeding, it is an astringent drug and it must comply with the required, final over-the-counter (OTC) drug monograph for "Skin Protectant Drug Products for Over-The-Counter Human Use--Astringent Drug Products." The agency further pointed out that the labeling for the product did not distinguish between active and inactive ingredients, and the labeling did not bear any warnings required to appear on the labeling for OTC astringent drug products, including, "Warning: For external use only. Avoid contact with the eyes." Lab, NDA