FDA Issues Warning Letters to Six Companies for Selling Misbranded Over-the-Counter Pain-Relief Products with Excessive Lidocaine Content

The U.S. Food and Drug Administration has issued warning letters to six companies for selling unapproved and misbranded over-the-counter topical pain-relief products containing higher-than-allowed concentrations of lidocaine, a local anesthetic. These products are commonly used by individuals who regularly undergo microdermabrasion treatments, laser hair removal, tattoos, or piercings.

According to Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, these products pose significant risks to consumers due to their excessive lidocaine content. Lidocaine can lead to serious side effects such as irregular heartbeat, seizures, and breathing difficulties when used on large areas of skin or irritated skin.

To prevent adverse effects from these products, the FDA recommends avoiding those containing more than 4% lidocaine and refraining from usage on large areas of skin. Individuals should also avoid wrapping the product with dressings or plastic wraps. Some of the products cited by the FDA in their warning include TKTX Numb Maximum Strength Pain Reliever, NumbSkin Lidocaine Numbing Creams, and Signature Tattoo Numbing Cream.

It is crucial for individuals undergoing cosmetic procedures to be aware of these warnings and take necessary precautions to protect their health and well-being while using these products. For more detailed information on specific products mentioned in the FDA’s warning, interested individuals can refer to the FDA’s official press release.