Saturday 16 January 2021

Antiseptic handrubs (FDA)

The U.S. Food and Drug Administration (FDA) has provided a question and answer document about antiseptic handrubs. This relates to over-the-counter consumer antiseptic rub products. This means those products described as t rubs, leave-on products, or hand sanitizers.

The Consumer Antiseptic Rub Federal Regulation has established that 28 active ingredients used in non-prescription consumer antiseptic rub products are not eligible for evaluation under FDA’s ongoing rulemaking to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972, which is known as the OTC Drug Review.

The ingredients not permitted are:
  • Benzalkonium cetyl phosphate 
  • Benzethonium chloride 
  • Cetylpyridinium chloride 
  • Chloroxylenol 
  • Chlorhexidine gluconate
  • Cloflucarban 
  • Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine
  • 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 
  • Polyhexamethylene biguanide
  • Povidone-iodine (5 to 10 percent)  
  • Salicylic acid 
  • Secondary amyltricresols 
  • Sodium hypochlorite
  • Sodium oxychlorosene 
  • Tea Tree Oil
  • Tribromsalan 
  • Triclocarban 
  • Triclosan 
  • Triple dye 
  • Undecoylium chloride iodine complex 


Drug products containing these active ingredients will require approval under a new drug application (NDA) or an abbreviated new drug application (ANDA) before they can be marketed.

The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rub products— benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are eligible for evaluation under the OTC Drug Review.



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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