FDA Issues Warning for Topical Analgesics with High Levels of Lidocaine

The US Food and Drug Administration (FDA) has issued a warning on some topical over-the-counter (OTC) analgesics marketed to treat pain due to excessively high concentration of ingredients including lidocaine.

In a statement Tuesday, the FDA announced the issuance of 6 warning letters to as many companies for “unapproved, misbranded products” that which may put consumers are risk of serious conditions including arrhythmia (irregular heartbeat), seizures, difficult breathing, and serious skin injury due to high concentrations of lidocaine.

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

Each of the OTC analgesic products are marketed to treat pain by topical administration around the time of cosmetic procedures including laser hair removal, microdermabrasion, piercings and tattooing. Among the companies to receive warning letters are:

• Dermal Source, Inc., for New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1.
• Indelicare (INKEEZE), for Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap.
• SeeNext Venture, Ltd., for NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams) and NumbSkin 10.56% Lidocaine Numbing Cream.
• Sky Bank Media, LLC (Painless Tattoo Co.), for Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray.
• Tattoo Number Cream Co., for Signature Tattoo Numbing Cream and Miracle Numb Spray.
• TKTX Company, for TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%.

The FDA additionally stressed that due to the high concentration of lidocaine in these products, an increased absorption of the drug products may result in unexpected interaction with medications or dietary supplements. With their warning, the agency reiterating their recommendation consumers and patients avoid topical OTC pain relief products with >4% lidocaine.

What’s more, the FDA advised consumers and patients to avoid “heavy” application of OTC pain relief products over large, irritated or broken areas of skin. They should additionally not wrap nor dress skin treated with such products, as it can increase the risk of serious adverse events.

Along with the warning letters, the FDA issued a request for the impacted companies to respond within 15 days of receipt stating their plans to address the raised issue or any supporting evidence as to why the product may be lawfully marketed as is.

“Failure to address violations promptly may result in legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing violative products,” the FDA stated. “Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.”

Reference

^{US Food & Drug Administration. FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects. Press release. Published March 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health}