Safety Announcement

[6-25-2014] 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. 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 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 FDA, we 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.



Manufacturers of OTC topical acne drug products have the option to add label directions for sensitivity testing for new users of their products (see Guidance for Industry). We encourage new users of OTC topical acne drug products to follow these directions. We are also encouraging manufacturers to add these directions to all product labels, to reduce the risk of serious hypersensitivity reactions. According to these directions, 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 3 days. If no discomfort occurs, then the product can be used according to the directions on the Drug Facts label. Consumers should avoid using an OTC topical acne product again if they have previously experienced a hypersensitivity reaction with its use.



We are continuing to monitor and evaluate this safety issue, and will work with manufacturers regarding any future label changes that would address the risk of severe hypersensitivity reactions.