The FDA has issued a warning that certain over-the-counter (OTC) topical acne medications may cause rare but serious and potentially life-threatening allergic reactions or severe irritation. The hypersensitivity reactions may occur within minutes to a day or longer after product use.

The OTC topical acne products addressed by the FDA are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products. Consumers are advised to stop using the topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue, or if they develop hives or itching. The FDA also advises consumers to apply a small amount of the OTC topical acne product to one or two small affected areas for three days prior to using it for the first time. This is to ensure that no hypersensitivity symptoms occur; if there is no discomfort, use as directed by the Drug Facts label.

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Currently it cannot be determined if the serious hypersensitivity reactions were triggered by the products’ active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both. The FDA will continue to monitor and evaluate this safety issue and work with manufacturers regarding any future label changes that would focus on the risk of severe hypersensitivity reactions.

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