FDA Approval - Final rule on Antiseptic Hand Sanitizers

FDA approved final rule on antiseptic hand sanitzers. FDA's final rule on antiseptic hand sanitizers made 28 active ingredients in OTC Monograph became ineligible for the status of "OTC consumer antiseptic rubs that are intended for use without water". Manufacturers using these ingredients need an FDA approval , NDA or ANDA to continue marketing with these ingredients.

This FDA final rule does not include antiseptic washes, healthcare antiseptics, first aid antiseptics, or antiseptics used by the food industry.

Hand Sanitizer - Active Ingredients

benzalkonium chloride, Alcohol (ethyl alcohol or ethanol, 60 to 95 percent), and isopropyl alcohol (70 to 91.3 percent) are still under FDA OTC Drug review and are eligible for marketing, manufacturers of hand sanitizers with these ingredients continue with FDA drug establishment registration renewal and drug listing update every year.

FDA Registration and NDC Number for Hand Sanitizer

Domestic (US Facility) hand sanitizer manufacturer must register their establishment with FDA within 5 calendar days after start manufacturing and complete hand sanitizer listing with 10-digit NDC Number within 3 days after establishment registration.

Foreign hand sanitizer manufacturer must complete registration and drug listing before Start marketing in the USA.

Hand Sanitizer GMP

Ineligible Ingredients

  • Benzethonium chloride
  • Chloroxylenol
  • Chlorhexidine gluconate
  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
  • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
  • Methylbenzethonium chloride
  • Nonylphenoxypoly (ethyleneoxy) ethanoliodine
  • Phenol (equal to or less than 1.5 percent or greater than 1.5 percent)
  • Poloxamer iodine complex
  • Povidone-iodine 5 to 10 percent
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye
  • Undecoylium chloride iodine complex
  • Polyhexamethylene biguanide
  • Benzalkonium cetyl phosphate
  • Cetylpyridinium chloride
  • Salicylic acid
  • Sodium hypochlorite
  • Tea tree oil
  • Combination of potassium vegetable oil solution, phosphate sequestering agent, and Triethanolamine

Certificate of FDA Registration - OTC Drugs

LMG assist foreign and domestic drug manufacturers to register with FDA , we also provide drug listing service and US FDA Agent service to foreign drug establishments. Please complete our online form to register your establishment with FDA.

Proof of FDA Registration

LMG issue free FDA registration certificate after successfully completing your establishment registration with FDA. You can use this as a proof of FDA registration to the industry, also you can verify certificate validity on our website.

FDA Certificate - Drug Registration