The pain relievers are used before, during, or after certain procedures.

Kristen Kazarian, Managing Editor

March 27, 2024

2 Min Read
FDA issues warning to six companies about OTC topical pain relievers
Some of the products are labeled to contain ingredients, such as lidocaine, at higher concentrations than what is permitted.Image courtesy of sasun bughdaryan / iStock / Getty Images Plus via Getty Images

The US Food and Drug Administration has issued a warning for consumers not to use certain over-the-counter pain relief products that are marketed for topical use to relieve pain before, during, or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing.

The agency issued warning letters to six companies for marketing these products in violation of federal law.

Some of the products are labeled to contain ingredients, such as lidocaine, at higher concentrations than what is permitted for over-the-counter, topical pain relief products. When these products with high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it could lead to serious injury such as irregular heartbeat, seizures, and breathing difficulties. These products may also interact with other medications or dietary supplements.

Additionally, when lidocaine is applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time and when the skin is covered, the product may cause serious injury. 

Despite FDA warnings to consumers about similar products over the past decade, the agency continues to find potentially dangerous products available online and in retail stores. The FDA is not aware of evidence demonstrating these products are safe.

The products in the warning letters are: 

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

  • Sky Bank Media LLC, dba 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

  • Indelicare, dba INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap

The FDA recommends 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.

  • not wrap skin treated with OTC pain relief products with plastic wrap or other dressings. Wrapping or covering treated skin with any type of material can increase the chance of serious side effects.

About the Author(s)

Kristen Kazarian

Managing Editor

Kristen Kazarian has been a writer and editor for more than three decades. She has worked at several consumer magazines and B2B publications in the fields of food and beverage, packaging, processing, women's interest, local news, health and nutrition, fashion and beauty, automotive, and computers.

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