What is the active ingredient in all FDA approved hand sanitizers?
FDA issued a final rule on April 11 regarding ban certain dangerous active ingredients in OTC hand sanitizer products. After reviewing the safety and effectiveness of hand sanitizers, the normative concluded a previous determination from FDA that, 28 active ingredients, including triclosan and benzethonium chloride, are not allowed in antiseptic hand sanitizer.
FDA said it also requires more information on three other active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—to check that products with these ingredients are safe and effective for common use by consumers. At the moment the FDA agency does not intend to remove from the market antiseptic hand sanitizers that contain these three active ingredients. Ethyl alcohol is the most common ingredient in hand sanitizers. The FDA recommendation is to use an alcohol-based hand sanitizer that contains at least 60% alcohol.
The FDA finally informed that products containing no-eligible active ingredients will require FDA approval under a new drug application or abbreviated new drug application prior to marketing.
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
-
If you intend to sell Hand Sanitizer in the USA and not sure about the procedure and regulations please contact our FDA regulatory consultant or call us +1 727 3509380 for the U.S.
