WASHINGTON -- The FDA warned Thursday of the risks of rare but serious chemical burns with certain over-the-counter topical pain relievers, including Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum.
The agency has noted a number of adverse event reports that range from burning sensations to hospitalizations for first- to third-degree burns within 24 hours of the first application.
Topical muscle and joint pain relievers are usually formulated as creams, lotions, ointments, and patches and contain menthol, methyl salicylate, or capsaicin as single or combination active ingredients.
The reports of second- and third-degree burns were mostly related to products with menthol or menthol and methyl salicylate as active ingredients, the agency said in a statement. In those products, menthol concentrations exceeded 3% and methyl salicylate concentrations exceeded 10%.
To reduce risk of the adverse events, the agency said, patients should avoid tightly bandaging or applying localized heat -- such as with heating pads or lamps -- after using the pain reliever.
Also, the agency noted, the products should not be applied to open wounds, broken skin, mucous membranes, or the eyes.
The agency added that, despite the serious adverse event reports, the products' labels would not be forced to carry a warning for the skin reactions at this time.
Cole Petrochko
Staff Writer
Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.
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