[Posted 06/25/2014] ISSUE: 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. The hypersensitivity reactions may occur within minutes to a day or longer after product use.
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.
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.
BACKGROUND: Based on the information reported to FDA, it cannot be determined 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. FDA is 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.
RECOMMENDATION: Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don't develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Benzoyl peroxide is used to treat mild to moderate acne.
Benzoyl peroxide comes in cleansing liquid or bar, lotion, cream, and gel for use on the skin. Benzoyl peroxide usually is used one or two times daily. Start with once daily to see how your skin reacts to this medication. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use benzoyl peroxide exactly as directed. Do not use more or less of it or use it more often than directed by your doctor.
The cleansing liquid and bar are used to wash the affected area as directed.
To use the lotion, cream, or gel, first wash the affected skin areas and gently pat dry with a towel. Then apply a small amount of benzoyl Peroxide, rub it in gently.
Avoid anything that may irritate your skin (e.g., abrasive soaps or cleansers, alcohol-containing products, cosmetics or soaps that dry the skin, medicated cosmetics, sunlight, and sunlamps) unless directed otherwise by your doctor.
It may take 4-6 weeks to see the effects of this medication. If your acne does not improve after this time, call your doctor.
Do not allow medication to get into your eyes, mouth, and nose.
Do not use benzoyl peroxide on children less than 12 years of age without talking to a doctor.
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.
dryness or peeling of skin
feeling of warmth
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Keep all appointments with your doctor. Benzoyl peroxide is for external use only. Do not let benzoyl peroxide get into your eyes, nose, or mouth, and do not swallow it. Do not apply dressings, bandages, cosmetics, lotions, or other skin medications to the area being treated unless your doctor tells you.
Keep benzoyl peroxide away from your hair and colored fabrics because it may bleach them.
Do not let anyone else use your medication. Tell your doctor if your skin condition gets worse or does not go away.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 07/15/2014
AHFS® Consumer Medication Information. © Copyright, 2014. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.