FDA Approval for Hand sanitizer

Hand sanitizers complying with FDA OTC Monograph does not require FDA Approval. FDA Approval (NDA or ANDA) is required for antiseptic hand sanitizer which does not complying with OTC Monograph.

Eligible Hand sanitizer active ingredients in FDA OTC Monograph

Benzalkonium chloride, Ethyl alcohol or Ethanol ( 60 to 95 percent) and Isopropyl alcohol (70 to 91.3 percent) are the only eligible active ingredients in OTC Monograph.

FDA Regulations for Hand Sanitizer Manufacturer

Even though the Hand sanitizer manufacturer follow the OTC Monograph, they have to comply with all other drug manufacturer requirements like

  • FDA Registration
  • NDC Number
  • Hand sanitizer listing
  • Hand sanitizer labeling compliance
  • GMP – Good Manufacturing Practice – Hand Sanitizer GMP

NDC Number for Hand Sanitizer

Each hand sanitizer must have a unique NDC number. if the difference is only in the package size the last segment of NDC number must be different. If the ingredient, proprietary name, intended use etc are different, a new NDC number must be assigned and separate drug listing is required.

Import requirements for Hand Sanitizer

if you are a private label distributor of hand sanitizer you need to comply with below requirements

  • NDC Labeler code
  • Hand sanitizer listing
  • Hand sanitizer labeling compliance

FDA Registration Process for Hand Sanitizer

FDA registraton process for hand sanitizer manufacturer includes

  • DUNS number reqeust
  • Manufacturing Establishment registration
  • Labeler code request for the establishment
  • Drug Listing Submission with 10 digit NDC number