FDA Alert: Unsafe OTC Numbing Products Identified
If you perform treatments like microneedling, tattoo removal, or laser hair removal, the latest FDA warning deserves your immediate attention.
The FDA announced enforcement actions against several companies selling over-the-counter (OTC) topical anesthetics with dangerously high concentrations of lidocaine—far exceeding the 4% limit approved for OTC use.
These products are widely marketed to aesthetic patients for pain relief, but they carry serious health risks and legal consequences.
Table of Contents
What Are the Risks?
- Irregular heartbeat
- Seizures
- Breathing issues
- Dangerous drug interactions
Products Called Out by the FDA
- TKTX products (including 40% lidocaine gel and 29.9% cream)
- NumbSkin creams (up to 10.56% lidocaine)
- Several other tattoo numbing sprays and creams from unapproved or foreign sources
What This Means for You
What it takes:
- Verify Lidocaine Concentration
- Reassess Application Practices
- Educate Your Patients
- Report Adverse Reactions
Stay Informed, Stay Trusted
“These products pose unacceptable risks to consumers and should not be on the market.”
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Sources:
- MedEsthetics Magazine. FDA Issues Warning on Certain OTC Analgesic Topical Products. April 1, 2024
- FDA Warning: FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects. March 26, 2024
