FDA Registration for Hand Sanitizer

Antiseptic hand sanitizers are OTC drugs requiring FDA establishment registration, drug listing, and NDC labeler code. LMG assists hand sanitizer manufacturers worldwide.

OTC Drug RegistrationNDC Labeler CodeSPL SubmissionSince 2009

FDA Approval - Final rule on Antiseptic Hand Sanitizers

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, 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.

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.