FDA issues warning on certain OTC acne products

WASHINGTON — The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation. 

The FDA stated that consumers should stop using their 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.  Consumers should also stop using the product if they develop hives or itching. 

These 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, the agency stated.

Based on the information reported to the FDA, it 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. 
According to the FDA’s statement, 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.

Before using an OTC topical acne product for the first time, consumers should apply a small amount to one or two small affected areas of the skin for three days, the FDA stated.  If no discomfort occurs, then the product can be used according to the directions on the Drug Facts label. 


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