FDA Registration OTC

Because hand sanitizers are considered over-the-counter (OTC) drug products, manufacturers, exporters, and importers must be registered as Drug Establishments with the FDA. Such registration requires the DUNS Number of each establishment. We also expect your company to provide an FDA compliant label, when contacting ITB HOLDINGS LLC.

ITB HOLDINGS LLC

390 North Orange Avenue, Suite 2300

Orlando, FL 32801

United States

T: +1 855 389 7344

T: +1 855 510 2240

T: +44 800 610 1577

www.itbhdg.com

https://www.itbhdg.com/blog/importing-hand-sanitizers/