FDA Warns Consumers About Unapproved, Misbranded OTC Analgesic Products

The FDA has issued warning letters to 6 companies that are marketing unapproved, misbranded OTC analgesic products.¹ These products are marketed for topical use to relieve pain before, during, or after certain cosmetic procedures including microdermabrasion, laser hair removal, tattooing, and piercing.

The agency is warning consumers to avoid using these products.

According to an agency news release, some of the product labels contain ingredients at concentrations higher than allowed for OTC topical analgesic products. Serious injury may occur when products containing high products of lidocaine are applied in ways that may lead to increased drug product absorption. Serious injuries can include irregular heartbeat, seizures, and difficulty breathing; additionally, there may be interactions with medications or dietary supplements.

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

READ MORE: Topical Analgesics: A New Frontier for First-Line Pain Management

The FDA recommends that consumers not use OTC pain relief products including more than 4% lidocaine on their skin. OTC pain relief products should not be applied heavily, over large areas of skin, or on irritated or broken skin, and consumers should not wrap skin that has been treated with OTC pain relief products with plastic wrap or other dressings; wrapping or covering lidocaine-treated skin can increase the chance of serious side effects.

A list of companies and products that received warning letters include:

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

Companies have been asked to respond to warning letters within 15 days of receipt, detailing how they will address these issues or providing reasoning and supporting information as to why these products are not in violation of the law. Failure to address the violations in a timely manner may result in legal action.

READ MORE: OTC Resource Center

Reference

1. 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 27, 2024. https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health