FDA hand sanitizer registration
US FDA sets temporary regulations for alcohol-based Hand Sanitizer
Because of the actual emergency situation caused by the COVID-19 in the United States, we are receiving a lot of inquiries about the FDA hand sanitizer registration process of Hand and wipe Sanitizer. So In this sense, the FDA issued a temporary policy expedite the registration faster. So manufacturers can follow temporary guidelines to sell hand sanitizer.
Active Ingredients used in Antiseptic Rubs
– Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution
– Glycerol (1.45% v/v)
– Hydrogen peroxide (0.125% v/v)
– Sterile distilled water or boiled cold water
FDA Hand Sanitizer Registration procedureÂ
– Ingredients Review against the FDA hand sanitizer regulations and prohibited or restricted ingredients list and monograph check;
– Label Review for compliance with FDA regulations with the drug facts and other applicable guidelines: claims, mandatory information, etc.
So If you intend to know the FDA Hand sanitizer registration process and not sure about it please contact our FDA regulatory consultant or call us +1 727 3509380 for the U.S. If you are also interested in registering Hand Sanitizer in Canada we are able to submit your application and get approved in one week only due to COVID 19 emergency
