Warning: These Topical Pain Relief Products are Dangerous! - MedWaste Management Warning: These Topical Pain Relief Products are Dangerous! - MedWaste Management

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FDA warning pain relief

Warning: These Topical Pain Relief Products are Dangerous!

The FDA has issued a stark warning to consumers about the use of over-the-counter topical pain medications. The medications listed in the warning letter are considered dangerous and should be avoided by consumers. While the products are available without a prescription, they are manufactured with high doses and may result in serious health outcomes.

The warning includes several companies and their products. They are each listed below. The FDA has allowed the companies 15 days to respond to the warning letters and take appropriate action.

At this time, the FDA is aware that reports have been made of consumers experiencing adverse events related to the use of these products.

The FDA issued a similar warning in 2009. See the full text here.

SUMMARY

Date of Warning:

Announced: March 26, 2024

Public Notification: April 8, 2024

Name(s) of Drug:

Drug names are listed below

Company Name:

Company names are listed below

Drug Indication:

Pain relief during and after microdermabrasion, laser hair removal, tattoo application, and piercings.

Product Description

Each medication is packaged in its own manufacturer’s packaging. See below for more information.

Reason for Warning

The FDA recommends that over-the-counter topical pain relief medications contain a maximum of 4% Lidocaine. These products contain higher-than-recommended dosages of Lidocaine, putting consumers at risk of serious health outcomes.

Warning Impacts

Consumers who use topical pain relief medications containing higher than 4% Lidocaine are at risk of severe reactions such as:

  • Irregular Heart Rate
  • Seizures
  • Difficulty Breathing

Additionally, using the medications during cosmetic procedures and applying the product over large areas of the skin increases the risk of poor health outcomes.

The FDA recommends that consumers never apply the products over a large area or a broken area of skin or wrap the area with plastic or other dressings.

Warning Product Information

Consumers possessing an over-the-counter topical pain relief product should compare their product with the chart below. If your product is included in the warning, read further for additional information.

Company Name
Product Name

TKTX Company

TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine

During Procedure Numbing Gel 40%

J-CAIN cream [LIDOCAINE] 29.9%

SeeNext Venture, Ltd.

5% Lidocaine Numbing Cream (15 grams) (NumbSkin)

5% Lidocaine Numbing Cream (30 grams) (NumbSkin)

NumbSkin 10.56% Lidocaine Numbing Cream

Tattoo Numbing Cream Co.

Signature Tattoo Numbing Cream

Miracle Numb Spray

Sky Bank Media, LLC dba 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 dba INKEEZE

Original B Numb Numbing Gel by Ink Eeze

Ink Eeze B Numb Numbing Spray Black Label

The Ink Eeze B Numb Numbing Foam Soap

FDA.gov

 

Have you found that you are in possession of drugs included in the warning? Here’s what you should do:

Consumers

If you find that you are in possession of drugs included in the warning, you should:

  1. Stop using the medication right away.
  2. Notify your doctor that you have used the medication.
  3. Monitor your health for any adverse symptoms and notify your physician if you have concerns.
  4. If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and consider removing stock included in the warning.
  2. Notify affected consumers of recalled batches that they have already or will receive.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and consider removing stock included in the warning.
  2. Notify affected retailers of recalled batches that they have already or will receive.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

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Learn How To Properly Manage & Dispose of Household Medical Waste

 

Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

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