Monday, September 17, 2012 FDA Encourages Reporting of Burns Caused by OTC Topical Pain Relievers The US Food and Drug Administration (FDA) is encouraging health care providers to report adverse events involving over-the-counter (OTC) topical muscle and joint pain relievers to the FDA MedWatch program. Last week, FDA alerted the public that certain OTC products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied. These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin. Based on the reported cases, the majority of second- and third-degree burns occurred with the use of products containing menthol as the single active ingredient, and products containing both menthol and methyl salicylate in concentrations greater than 3% menthol and 10% methyl salicylate. The various formulations include creams, lotions, ointments, and patches. The products are marketed under various brand names, such as, Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum.