SILVER SPRING, Md. — The Food and Drug Administration on Thursday alerted the public that certain external analgesics have been associated with burns. Most of the reported cases involved products containing higher concentrations of menthol and methyl salicylate (greater than 3% menthol or 10% methyl salicylate). Few of the cases involved capsaicin, the FDA reported.
Over 42 years, as many as 43 reported cases of burns associated with use of external pain relievers for muscle pain or joint pain have been reported, noted FDA chemist Reynold Tan. While that represents a small incidence relative to the number of external analgesics sold, those products should not be causing burns.
"[However,] existing Tentative Final Monograph does not at this time require labels of OTC topical muscle and joint pain relievers to carry a warning that use of the products could result in serious burns," the FDA stated. The FDA advised consumers using these products to not bandage the area of pain tightly or apply local heat (e.g., heating pads, lamps, hot water). Further, the FDA advised consumers to not use external analgesics on broken or irritated skin.
For the 52 weeks ended Aug. 12, sales of external analgesic rubs totaled $305.9 million, up 1.7%, across food, drug and mass (minus Walmart) channels, according to SymphonyIRI Group data.