FDA Warns 6 Brands for Marketing Unapproved Topical Pain Relievers

The US Food and Drug Administration has issued a warning for consumers not to use certain over-the-counter pain relief products that are marketed for topical use to relieve pain before, during, or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing.

The agency issued warning letters to six companies for marketing these products in violation of federal law.

Some of the products are labeled to contain ingredients, such as lidocaine, at higher concentrations than what is permitted for over-the-counter, topical pain relief products. When these products with high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it could lead to serious injury such as irregular heartbeat, seizures, and breathing difficulties. These products may also interact with other medications or dietary supplements.

Additionally, when lidocaine is applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time and when the skin is covered, the product may cause serious injury. 

Despite FDA warnings to consumers about similar products over the past decade, the agency continues to find potentially dangerous products available online and in retail stores. The FDA is not aware of evidence demonstrating these products are safe.

The products in the warning letters are: 

The FDA recommends consumers: