FDA Bans OTC Marketing of Health Care Antiseptics with Triclosan

hand sanitizerEffective December 20, 2018, the US Food and Drug Administration (FDA) will prohibit over-the-counter (OTC) marketing of health care antiseptic hand soaps and sanitizers that contain the active ingredient triclosan, according to a final rule filed by the agency this week.


Health care antiseptic products that include triclosan, along with 23 other ingredients not currently used in any marketed antiseptics, will have to file a new drug application and undergo pre-market review.

Most OTC antiseptics will be unaffected by the new rule, since triclosan is the only active ingredient on the list of 24 banned ingredients currently used in marketed health care antiseptics. Six commonly used active ingredients—ethanol, propanol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX)—were not included on the banned-ingredients list to give the industry more time to complete studies on their safety and efficacy.

Health care antiseptics currently marketed under new drug applications are not affected by the rule.

Triclosan, in particular, was outed as an only partially effective antibacterial agent in a Journal of Infectious Diseases study a decade ago. Researchers from the University of Michigan reported the ingredient did not hinder the growth of Pseudomonas aeruginosa, Serratia marcescens, and other Gram-negative bacteria.

Jolynn Tumolo