Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Benzoyl peroxide topical (for the skin) is used to treat acne.

There are many brands and forms of benzoyl peroxide available. Not all brands are listed on this leaflet.

Benzoyl peroxide topical may also be used for purposes not listed in this medication guide.

Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: hives, itching; difficult breathing, feeling light-headed; or swelling of your face, lips, tongue, or throat.

Benzoyl peroxide topical can cause a rare but serious allergic reaction or severe skin irritation. Before you start using this medicine, you may choose to apply a "test dose" to see if you have a reaction. Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day.

Use exactly as directed on the label, or as prescribed by your doctor.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or on sunburned, windburned, dry, or irritated skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Wash your hands before and after applying this medication.

Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

You may need to shake the medicine just before each use.

Do not cover the treated skin area unless your doctor has told you to.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Acne:

Gel/cream/liquid/lotion/bar/foam: Start with 1 application per day, then gradually increase to 2 or 3 times per day if needed or as directed by a healthcare provider
Cloth: Wash affected areas once or twice per day, or as directed by a healthcare provider

Comments:
-Clean the skin thoroughly before applying this drug.
-If dryness or peeling occurs, reduce application to once a day or every other day.
-If going outside, apply sunscreen after using this product.
-If irritation or sensitivity develops, discontinue use and ask a healthcare provider.

Use: Treatment of acne vulgaris

Usual Pediatric Dose for Acne:

12 years or older:
Foam: Start with 1 application per day, then gradually increase to 2 or 3 times per day if needed or as directed by a healthcare provider

Comments:
-Clean the skin thoroughly before applying this drug.
-If dryness or peeling occurs, reduce application to once a day or every other day.
-If going outside, apply sunscreen after using this product.
-If irritation or sensitivity develops, discontinue use and ask a healthcare provider.

Use: Treatment of acne vulgaris

You should not use benzoyl peroxide if you are allergic to it, or if you have:

• very sensitive skin.

Ask a doctor or pharmacist if benzoyl peroxide topical is safe to use if you have any skin conditions or allergies.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not use this medicine on a child without medical advice.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Rinse with water if benzoyl peroxide topical gets in your eyes or mouth.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Benzoyl peroxide topical can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward.

Stop using benzoyl peroxide topical and get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using benzoyl peroxide and call your doctor at once if you have any of these side effects on the treated skin:

• severe itching or burning;

• severe stinging or redness;

• swelling; or

• peeling.

Common side effects of benzoyl peroxide topical may include:

• mild stinging or burning;

• itching or tingly feeling;

• skin dryness, peeling, or flaking; or

• redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applying benzoyl peroxide while you are also using tretinoin topical medicine may cause severe skin irritation. Brands that contain tretinoin include Avita, Renova, Retin-A, Tretin-X, and others.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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.

• Acanya® (containing Benzoyl Peroxide, Clindamycin)
• Bencort® (containing Benzoyl Peroxide, Hydrocortisone)
• Benzaclin® (containing Benzoyl Peroxide, Clindamycin)
• Benzamycin® (containing Benzoyl Peroxide, Erythromycin)
• Duac® (containing Benzoyl Peroxide, Clindamycin)
• Epiduo® (containing Benzoyl Peroxide, Adapalene)
• Face Up® (containing Benzoyl Peroxide, Sulfur)
• Inova 8-2® (containing Benzoyl Peroxide, Salicylic Acid)
• NuOx® (containing Benzoyl Peroxide, Sulfur)
• Sulfoxyl® (containing Benzoyl Peroxide, Sulfur)
• Vanoxide-HC® (containing Benzoyl Peroxide, Hydrocortisone)