FDA Cautions Against Specific Topical Pain Relief Due to Risk of Harmful Health Consequences: Agency Sends Notices to Six Companies for Selling Unapproved, Mislabeled Products

Despite repeated warnings from the FDA to consumers regarding similar products in the past decade, it is alarming to discover that potentially dangerous products are still being sold online and in retail stores. The FDA has not found any evidence to suggest that these products are safe for use.

The FDA cautions against using specific over-the-counter pain relief products meant for topical application during cosmetic procedures like microdermabrasion, laser hair removal, tattooing, and piercing. Six companies have received warning letters for unlawfully marketing these items.

Certain products have been found to have ingredients, like lidocaine, at levels that exceed the permitted concentration for over-the-counter pain relief products. If these products, which contain high amounts of lidocaine and are meant to be used before or during cosmetic procedures, are applied in a manner that enhances absorption through the skin, it can result in severe consequences such as irregular heartbeat, seizures, and breathing problems. Additionally, these products can potentially interact with medications or dietary supplements that a consumer may be using.

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

Despite repeated warnings from the FDA to consumers regarding similar products in the past decade, it is alarming to discover that potentially dangerous products are still being sold online and in retail stores. The FDA has not found any evidence to suggest that these products are safe for use.

Furthermore, it is important to note that when lidocaine is applied to large areas of the skin, especially if the skin is already irritated or broken, and if the product is left on for extended periods of time while covered, it can lead to serious injury.

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The FDA has specifically identified several products in their warning letters. These include:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40%, J-CAIN cream [LIDOCAINE] 29.9% from TKTX Company

• SeeNext Venture, Ltd: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), NumbSkin 10.56% Lidocaine Numbing Cream from SeeNext Venture, Ltd.

• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray

• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray

• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1 from Dermal Source, Inc.

• Indelicare, doing business as INKEEZE.: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label, and Ink Eeze B Numb Numbing Foam Soap from Indelicare (doing business as INKEEZE) are also included in the list of products to be cautious of.

The FDA advises against using over-the-counter pain relief products containing more than 4% lidocaine on the skin, avoiding heavy application over large areas or on irritated skin, and refraining from wrapping treated skin with plastic wrap or dressings. Reports of adverse events have prompted the FDA to urge consumers and healthcare professionals to report any issues to the MedWatch Adverse Event Reporting program for necessary action.

The FDA has requested that the companies reply to the warning letters within 15 days upon receiving them. They should outline their plans to resolve the mentioned issues or present their arguments along with supporting evidence to justify why they believe their products are not in violation of the law.

Failing to address these violations promptly could lead to legal consequences, such as the seizure of their products or a court order to cease manufacturing and distributing non-compliant items. Furthermore, the agency has taken action by placing certain companies on import alert to prevent their products from entering the U.S. market and reaching consumers.

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