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.

benzalkonium chloride, ethyl alcohol, and isopropyl alcohol 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.

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

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FDA Certificate - Drug Registration