Published On: 6.26.2014 Charlotte, NC

FDA Warning For Topical Acne Products

On behalf of Robert Dill of Charles G. Monnett III & Associates


The FDA has issued a warning for certain acne treatments saying they can cause severe allergic reactions that can be potentially life-threatening.

The warning includes the use of certain acne products containing the active ingredients benzoyl peroxide or salicylic acid, the active ingredient that makes the medicine effective against the illness or condition it is treating.

The acne products are sold over-the-counter (OTC) and applied to the skin (topical). Their serious allergic reactions differ from the less harmful irritations already included in the product Drug Facts labels, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, M.D., a medical officer at FDA. “It’s important that consumers know about them, and that they know what to do if they occur.”

Products of concern are marketed under different brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. They are available as gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs.

The FDA has received 131 reports from both consumers and manufacturers of allergic and hypersensitivity-related adverse reactions associated with these products. About 42% of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11 to 78 years.

Types of Reactions

Forty percent of these reports described severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting or collapse. Isolated instances of hives, itching of face or body (even of parts of the body where the person did not apply the medication), and swelling of eyes, face and lips were also reported.

While no deaths have been reported, 44% of the cases required hospitalization.

What to Do If a Bad Reaction Occurs

She adds that there are a number of important safety actions to counter an allergic reaction, including:

· Avoid using the product if you’ve had previous allergic or hypersensitivity reactions.

· Stop using the product if you develop hives or itching of the face or body.

· Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue; feel faint; or have difficulty breathing.

We Can Help

The Law Offices of Charles G. Monnett III & Associates has successfully represented clients across the United States injured in dangerous and defective product cases.

If you or a family member have been severely injured, please contact the Law Offices of Charles G. Monnett III & Associates for a no-cost, prompt and confidential evaluation of your case. Call us today at 704.376.1911 or toll-free at 800.977.3077, 24-hours a day, seven days a week.