[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.
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
Topical salicylic acid comes as a cloth (a pad or wipe used to cleanse the skin), cream, lotion, liquid, gel, ointment, shampoo, wipe, pad, and patch to apply to the skin or scalp. Topical salicylic acid comes in several strengths, including certain products that are only available with a prescription. Topical salicylic acid may be used as often as several times a day or as infrequently as several times a week, depending on the condition being treated and the product being used. Follow the directions on the package label or your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use salicylic acid exactly as directed. Do not use more or less of it or use it more often than directed on the package or prescribed by your doctor.
If you are using topical salicylic acid to treat acne, your skin may become dry or irritated at the beginning of your treatment. To prevent this, you may apply the product less often at first, and then gradually begin to apply the product more often after your skin has adjusted to the medication. If your skin becomes dry or irritated at any time during your treatment, you may apply the product less often. Talk to your doctor or check the package label for more information.
Do not swallow topical salicylic acid. Be careful not to get topical salicylic acid in your eyes, nose, or mouth. If you accidentally get topical salicylic acid in your eyes, nose, or mouth, flush the area with water for 15 minutes.
Do not apply topical salicylic acid to skin that is broken, red, swollen, irritated, or infected.
Only apply topical salicylic acid to the areas of skin that are affected by your skin condition. Do not apply topical salicylic acid to large areas of your body unless your doctor tells you that you should. Do not cover the skin where you applied topical salicylic acid with a bandage or dressing unless your doctor tells you that you should.
If you are using topical salicylic acid to treat acne or certain other skin condition, it may take several weeks or longer for you to feel the full benefit of the medication. Your condition may worsen during the first few days of treatment as your skin adjusts to the medication.
Read the package label of the topical salicylic acid product you are using very carefully. The label will tell you how to prepare your skin before you apply the medication, and exactly how you should apply the medication. Follow these directions carefully.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
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 extra topical salicylic acid to make up for a missed dose.
stinging in the area where you applied topical salicylic acid
extreme tiredness or weakness
ringing or buzzing in the ears
Topical salicylic acid may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
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.
If someone swallows salicylic acid or applies too much salicylic acid, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
extreme tiredness or weakness
ringing or buzzing in the ears
Keep all appointments with your doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using topical salicylic acid.
If you are using prescription strength topical salicylic acid, do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
Ask your pharmacist any questions you have about topical salicylic acid.
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 - 06/25/2014
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.