Important Advice from the FDA about Using OTC Products

Woman Neck Pain Image

According to the U.S. Food and Drug Administration (FDA), some over-the-counter (OTC) products used to relieve muscle or joint pain can cause serious skin injuries—even when used as directed, and sometimes after just one use. Topical pain relievers, including creams, lotions, ointments, balms and patches, may be used to treat arthritis, back pain, minor sprains and strains and other conditions. The FDA notes that the number of injuries caused by these products is very small when compared to the number of people who regularly use them.

First-, second- or third-degree chemical burns have been reported after using topical pain relievers that contain menthol, methyl salicylate or capsaicin. These ingredients, which temporarily relieve pain and produce a sensation of warmth or coolness when applied to the skin, are found in products like Bengay, Capzasin, Flexall, Icy Hot, Mentholatum and others. If you experience redness, burning pain, swelling or blistering of the skin after using a topical pain reliever, stop using the product and contact your health care provider immediately.

In September 2012, the FDA announced that most of the serious injuries reported occurred with pain relievers containing menthol as the single active ingredient and those that listed higher concentrations of menthol (greater than 3 percent) and methyl salicylate (10 percent). A small number of injuries involved products that contain capsaicin.

When using OTC pain relievers—oral or topical—it's important to follow all instructions carefully and use them only as directed. If you have questions about pain medications, talk to your health care provider or pharmacist.

Safety precautions from the FDA regarding the use of topical pain relievers include the following:

  1. Never apply topical pain relievers to irritated or damaged skin.
  2. After applying a topical pain reliever, don't cover the area (e.g., with a bandage)
  3. Don't apply heat to the area (e.g., using a heating pad or hot water bottle).
  4. Don't allow topical pain relievers to come in contact with your eyes or genitals or apply them to the sensitive skin inside your nose or mouth (mucous membranes).

Contact your health care provider if you experience unexpected side effects, burning pain, redness, swelling or blistering after using a topical pain reliever.

Source: U.S. Food and Drug Administration (FDA)

Publication Review By: the Editorial Staff at

Published: 17 Sep 2012

Last Modified: 10 Nov 2014