FDA Issues Dire Warning on Dangerous Pain Relief Creams

In a stark advisory, the U.S. Food and Drug Administration (FDA) has sounded the alarm on a selection of over-the-counter topical pain relief creams and gels ¹, citing illicit and potentially hazardous levels of ingredients, notably the drug lidocaine.

Unveiling a list of six products tailored for topical use before, during, or after cosmetic procedures such as microdermabrasion, laser hair removal, tattooing, and piercing, the FDA has raised grave concerns regarding their safety.

Some of these products contain lidocaine in concentrations exceeding the permissible limit for over-the-counter use.

When applied in manners that foster heightened absorption through the skin, these creams and gels pose severe health risks, including but not limited to irregular heartbeat, seizures, and respiratory distress, the agency warned. Moreover, there’s a significant risk of adverse interactions with other medications or dietary supplements.

Jill Furman, J.D., the director of the Office of Compliance within the FDA’s Center for Drug Evaluation and Research, minced no words, asserting, “These products pose unacceptable risks to consumers and should not be on the market.”

Furman emphasized the FDA’s unwavering commitment to leveraging all available resources to quash the sale of these illicit and high-risk products.

In a decisive move, the FDA disclosed that it had dispatched warning letters to six companies found to be marketing these products in flagrant violation of federal law. The implicated entities include TKTX Company, SeeNext Venture, Ltd., Tattoo Numbing Cream Co., Sky Bank Media, LLC (operating as Painless Tattoo Co.), Source, Inc., and Indelicare (trading as INKEEZE).

The FDA has published a comprehensive list of the offending products, including:

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

Citing awareness of adverse events linked to the use of these products, the FDA urged consumers to promptly report any such incidents to the agency. Furthermore, the FDA stressed that there is no evidence attesting to the safety of these products.

To safeguard public health, the agency has issued several recommendations: consumers are advised against using over-the-counter pain relief products containing more than 4% lidocaine on their skin; they should refrain from applying such products excessively over large areas of skin or on irritated or broken skin; and they are cautioned against wrapping treated skin with plastic wrap or other dressings, as this practice can escalate the risk of serious side effects.

Stay tuned for further updates as this story develops.

Reference: fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health

Martha A. Lavallie
Martha A. Lavallie
Author & Editor | + posts

Martha is a journalist with close to a decade of experience in uncovering and reporting on the most compelling stories of our time. Passionate about staying ahead of the curve, she specializes in shedding light on trending topics and captivating global narratives. Her insightful articles have garnered acclaim, making her a trusted voice in today's dynamic media landscape.