FDA Warns Consumers Not to Use Certain Topical OTC Pain Relief Products 

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers to not use certain over-the-counter (OTC) pain relief products due to the potential for dangerous health effects.

These analgesic products are marked for topical use to relieve pain associated with certain cosmetic procedures such as microdermabrasion, laser hair removal, tattooing and piercing and are typically used before, during, or after treatment. However, according to the FDA, some of these products contain over the permitted limit of lidocaine for OTC products.

The FDA press release states, “When these products that contain 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 may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking.”

Furthermore, when lidocaine is applied over large areas of skin for a prolonged period of time, especially if the skin is irritated or broken, it can cause serious injury.

The FDA has issued warning letters to the companies of the products named below and has asked for a response within 15 days.

  • 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 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams) and NumbSkin 10.56% Lidocaine Numbing Cream
  • Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1

“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.”

The FDA has further issued the below recommends to consumers:

  • Not to use OTC pain relief products that contain more than 4% lidocaine on their skin.
  • Not to apply OTC pain relief products heavily over large areas of skin or to skin that is irritated or broken.
  • Not to wrap skin treated with OTC pain relief products with plastic wrap or other dressings as this can increase the chance of serious side effects.


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