FDA issues warning letters for unapproved topical pain relief products

On March 26, 2024, the United States FDA published a press release informing consumers of six warning letters sent to companies regarding unauthorized topical pain relief products. The following companies received letters for the indicated products.

• TKTX received a warning letter regarding its TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During procedure Numbing Gel 40%, and J-CAIN cream [Lidocaine] 29.9%.
• SeeNext Venture Ltd received a warning letter for its NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream.
• Tattoo Numbing Cream Co. got a warning letter for its Signature Tattoo Numbing Cream and Miracle Numb Spray.
• Sky Bank Media, sold under Painless Tattoo Co, received a letter for its Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray.
• Dermal Source Inc. received letters for the New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1.
• Indelicare, sold under INKEEZE, got warning letters for Ink Eeze Original B Numb Numbing Gel, Ink Eeze Original B Numb Numbing Spray, and Ink Eeze Original B Numb Numbing Foam Soap.

Each of these products was marketed as a topical pain relief product for use before, during, or after cosmetic procedures, including microdermabrasion, laser hair removal, tattoos, and piercing.

According to the FDA announcement, these products have concentrations of lidocaine that exceed the acceptable limit of the compound in over-the-counter products, which poses a significant threat to patients. High concentrations of lidocaine in topical products may result in inappropriate drug absorption that causes irregular heartbeats, seizures, breathing difficulties, or other interactions with medications or supplements.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in the release. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

The FDA is cautioning consumers to avoid over-the-counter topical pain relief products with more than 4% lidocaine. Additionally, consumers should refrain from applying these products on large areas of skin, especially irritated or broken skin. Consumers also should avoid covering their skin when treating it with similar products.