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Serious Adverse Events Linked to OTC Acne Products FDA Warns

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Washington, DC: The U.S. Food and Drug Administration (FDA) is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

Specifically, the reactions include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue, hives or itching.

According to the FDA, these serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels.

Based on the information reported to the FDA, the agency cannot determine if the serious hypersensitivity reactions were triggered by the acne products' active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both.

The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern 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.



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