Over-the-Counter Topical Acne Products: Rare But Serious Hypersensitivity Reactions

The FDA warns Pharmacy, Family Practice healthcare personnel certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

Neutrogena, Over-the-Counter Topical, Acne Products, Serious Hypersensitivity Reactions,

Background of Topical Acne Products

The OTC topical acne products of concern are marketed under various brand names such as Ambi, Aveeno, Clean & Clear, MaxClarity, Neutrogena, Oxy, Proactiv and as store brands. They are distributed as face scrubs, toners, cleansing pads, solutions, face washes, gels, lotions, and other products.

FDA Alert on Topical Acne Products

Over-the counter topical acne products can cause rare but serious, potentially life-threatening, allergic reactions or severe irritation such as swelling of the eyes, face, lips, or tongue; feeling faint; throat tightness; or difficulty breathing. In this case or if consumers develop itching or hives, they should stop using the product. These symptoms may occur within minutes to a day or longer after product use.

FDA Recommendation on Topical Acne Products

“Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label.”

Contacting the FDA to report cases with Topical Acne Products

In case of detection of adverse events or side effects related to the use of Topical Acne Products , healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

  • The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
  • The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
  • The completed form can be faxed to: 1-800-FDA-0178

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