FDA Issues Warning Letters About Certain Pain Relief Products Containing Lidocaine

March 28, 2024
The products, marketed for use before, during, and after certain cosmetic procedures, can cause severe injury

The FDA has issued a warning to consumers “not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures.” Some ingredients in the products, such as lidocaine, are at issue, as these products contain “concentrations that are higher than what is permitted for over-the-counter, topical pain relief products.”

When these products, intended to be used before or during certain cosmetic procedures like microdermabrasion, laser hair removal, tattooing, and piercing, are “applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures, and breathing difficulties.”

The products in the warning letters include pain relievers from TKTX Company, SeeNext Venture, Ltd., Tattoo Numbing Cream Co., Sky Bank Media, LLC, “doing business as Painless Tattoo Co.,” Dermal Source, Inc., and Indelicare, “doing business as INKEEZE.”

The FDA specifically recommends that consumers “not use OTC pain relief products with more than 4% lidocaine on their skin,” “not apply OTC pain relief products heavily over large areas of skin or to irritated or broken skin,” and “not wrap skin treated with OTC pain relief products with plastic wrap or other dressings.”

FDA has issued similar warnings to consumers over the past decade, but “the agency continues to find potentially dangerous products available online and in retail stores.” They have asked the companies to “respond to the warning letters within 15 days of receipt stating how they will address these issues or provide their reasoning and supporting information as to why they think the products are not in violation of the law.”

The FDA’s website has the news release, including the full list of products the warning letters target.