The FDA's OTC antiperspirant monograph lists aluminum salts (such as aluminum chlorohydrate and aluminum zirconium complexes) as the recognized active ingredients. Products containing these at approved concentrations must be labeled as OTC drugs with drug-facts panels, manufactured under drug GMPs, and imported through the drug admissibility pathway — not the cosmetic pathway. Using the wrong entry classification can result in detention or refusal at the port.

US classification is based on the product's intended use and labeling in the US market, not its foreign regulatory status. Even if the product is sold as a cosmetic abroad, any antiperspirant claim or aluminum-based active ingredient triggers OTC drug treatment in the US. Importers should relabel or reformulate as needed before shipment, and consult a licensed customs broker or regulatory counsel to confirm the correct admissibility pathway.