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ICMC 해외인증경영센터 / FDA 담당자 입니다.

미국에 손소독제 수출시, FDA 에 OTC Drug (의약외품)로 등록 하셔야 됩니다.

손소독제의 영문 정식 명칭은 Hand Sanitizer 이며,

미국에 현재 판매되는 알코올 함량 (Ethyl alcohol)은 62-70% 입니다.

Hand Sanitizer FDA Registration & Approval

Hand Sanitizer FDA Registration is mandatory for all type of antiseptic hand sanitizers manufactured or imported and sold in United States of America.

Generally Antiseptic Hand Sanitizers are considered as OTC drugs and NOT a Cosmetics by FDA regulation. The major reason for this is it contains either any one of the below listed active ingredients such as Benzalkonium Chloride, Ethyl Alcohol, Ethanol (62 to 70 %), Isopropyl Alcohol.

Due to this reason Hand sanitizers are called Over The Counter (OTC) drugs.

The following are the procedure to market in USA.

US Agent for Foreign Importers.

NDC / Labeler Code Request

FDA Establishment Registration (Manufacturer / Labeler (Brand Owner)

Drug Listing

미국 FDA OTC 등록 관련 상세한 문의는 02-2-2028-3111 로 연락 주시길 바랍니다.

감사합니다.

ICMC 해외인증경영센터 / FDA 담당자