Safety Alerts & Recalls

What does this mean?

Please be aware that a small number of people have had serious allergic reactions to OTC topical acne medicines. You should stop using a topical acne product and seek emergency medical attention immediately if you experience a reaction such as

- throat tightness;

- difficulty breathing;

- feeling faint; or

- swelling of the eyes, face, lips, or tongue.

You should also stop using the product if you develop hives or itching. Do not use an OTC topical acne product again if you have previously experienced a serious allergic reaction from it.

If you are using an OTC topical acne product for the first time, apply a small amount to one or two small affected areas of the skin for 3 days to make sure you don’t develop any symptoms of an allergic reaction. If no discomfort occurs, follow the directions on the Drug Facts label found on the container or packaging.

Please talk to a healthcare professional if you have any concerns about using OTC topical acne products.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

FDA Warns That Over-the-Counter Topical Acne Medicines May Cause Serious Allergic Reactions

The US Food and Drug Administration (FDA) has warned that over-the-counter (OTC) topical acne products can cause rare but possibly life-threatening allergic reactions, including symptoms of throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. The allergic reaction may occur within minutes to a day or longer after using the product. These symptoms of a serious allergic reaction differ from the labeled side effects which include redness, burning, dryness, itching, peeling, or slight swelling of the skin.

The OTC topical acne products of concern contain benzoyl peroxide or salicylic acid and 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. Based on the information received so far, the FDA has not been able to determine if the serious allergic reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-06-30
Last Updated: 2014-06-30

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