Disinfectants Packaged for Retail Sale or as Preparations

Products intended to disinfect inanimate surfaces are regulated by EPA as pesticides under FIFRA and classified here. Products intended for use on living tissue — such as hand sanitizers or surgical scrubs — are regulated by FDA as OTC drugs and classified under pharmaceutical headings. A product that makes both surface and skin-contact claims may be subject to dual jurisdiction, and importers should obtain written regulatory guidance before importing such products.

CBP verifies that the EPA registration number appears on the label, that the label language matches the EPA-registered master label (including use directions and precautionary statements), and that the net contents and active ingredient concentration are accurately stated. Shipments with labels that deviate from the registered version — even in translation — are subject to refusal of admission.