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FDA Issues Warning Letters to 6 Companies Marketing Misbranded OTC Topical Analgesics


Specifically, the topical analgesics, available over the counter, may contain higher than labeled concentrations of lidocaine, according to the agency.

The FDA has issued warning letters to 6 companies that are marketing unapproved, misbranded topical OTC analgesic products. These products are marketed for use to relieve pain before, during, or after certain cosmetic procedures including microdermabrasion, laser hair removal, tattooing, and piercing.

Labels for some of the products indicate that they contain concentrations of certain ingredients, such as lidocaine, higher than allowed for the product category, according to a news release from the agency. The agency warns of the potential for serious injury from application of a topical analgesic with a high concentration of lidocaine in ways that lead to increased transdermal absorption including arrhythmias, seizures, and difficulty breathing. There is also the potential for drug-drug interactions between lidocaine and medications or supplements the individual is taking.

The agency has received reports of adverse events related to the products and encourages both consumers and health care professionals to report any known adverse events to the
MedWatch Adverse Event Reporting program

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

The FDA recommends that consumers not use OTC topical analgesic products that contain more than 4% lidocaine. on their skin. The agency states that OTC topical pain relief products should not be applied heavily, over large areas of skin, or on irritated or broken skin; further, and of high importance, skin that has been treated with an OTC topical analgesic containing lidocaine should not be wrapped with dressings of any kind, including plastic wrap; occlusion of lidocaine-treated skin increases transdermal absorption and can increase the risk of serious adverse events, according to the FDA.

The FDA has given the 6 companies 15 days to respond to the warning letters including details of how the issues are to be addressed or providing information to support why their products do not violate current law. Legal consequences for noncompliance include product seizure or a court order to cease manufacturing. The agency also reports it has placed some of the companies on “import alert” to prohibit their products from entering the US.

The agency provided this list of companies that received warning letters and the products in question:

TKTX Company

  • 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 g)
  • NumbSkin 5% Lidocaine Numbing Cream (30 g)
  • 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

Source: FDA warns consumers to avoid certain topical pain relief products due to potential for dangerous health issues. News release. FDA. March 26, 2024. Accessed March 29, 2024. https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health

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