Patient information: uses, side effects, how to take - Adapalene and Benzoyl Peroxide
What is adapalene and benzoyl peroxide gel?
Adapalene and benzoyl peroxide gel is a prescription medicine used on the skin (topical) to treat acne vulgaris.
It is not known if adapalene and benzoyl peroxide gel is safe and effective in children under 12 years of age.
Do not use adapalene and benzoyl peroxide gel if you have had an allergic reaction to benzoyl peroxide or any of the ingredients in adapalene and benzoyl peroxide gel. See the end of this Patient Information leaflet for a complete list of ingredients in adapalene and benzoyl peroxide gel.
Before using adapalene and benzoyl peroxide gel, tell your doctor about all of your medical conditions, including if you:
- have other skin problems, including cuts, abrasions, sunburn or eczema.
are pregnant or plan to become pregnant. It is not known if adapalene and benzoyl peroxide gel can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if adapalene and benzoyl peroxide passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use adapalene and benzoyl peroxide gel. If you use adapalene and benzoyl peroxide gel while breastfeeding, use adapalene and benzoyl peroxide gel on the smallest area of the skin and for the shortest time needed. Do not apply adapalene and benzoyl peroxide gel directly to the nipple and the areola to minimize contact with your baby.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use adapalene and benzoyl peroxide gel?
- Use adapalene and benzoyl peroxide gel exactly as your doctor tells you to use it.
- Apply adapalene and benzoyl peroxide gel 1 time a day.
- Do not use more adapalene and benzoyl peroxide gel than you need to cover the treatment area. Using too much adapalene and benzoyl peroxide gel or using it more than 1 time a day may increase your chance of skin irritation.
Applying adapalene and benzoyl peroxide gel:
Wash the area where the gel will be applied with a mild or soapless cleanser and pat dry.
- Adapalene and benzoyl peroxide gel comes in a pump. Depress the pump to dispense a small amount (about the size of a pea) of adapalene and benzoyl peroxide gel and spread a thin layer over the treatment area. Use a pea-sized amount for each area of the face (forehead, chin, and each cheek).
- Wash your hands right away after applying the gel. Adapalene and benzoyl peroxide gel may bleach your hair or colored fabrics. Allow adapalene and benzoyl peroxide gel to dry completely before dressing to prevent bleaching of your clothes.
What should I avoid while using adapalene and benzoyl peroxide gel?
- Avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene and benzoyl peroxide gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. Use sunscreen and wear a hat and clothes that cover the areas treated with adapalene and benzoyl peroxide gel if you have to be in sunlight.
- Cold weather and wind may irritate skin treated with adapalene and benzoyl peroxide gel.
- Avoid applying adapalene and benzoyl peroxide gel to cuts, abrasions, and sunburned skin.
- Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes.
- Avoid the use of “waxing” as a hair removal method on skin treated with adapalene and benzoyl peroxide gel.
What are the possible side effects of adapalene and benzoyl peroxide gel?
Adapalene and benzoyl peroxide gel may cause serious side effects including:
- Allergic reactions. Stop using adapalene and benzoyl peroxide gel and get medical help right away if you have any of the following symptoms during treatment with adapalene and benzoyl peroxide gel:
- hives, rash or severe itching
- swelling of your face, eyes, lips, tongue, or throat
- trouble breathing or throat tightness
- feeling faint, dizzy, or lightheaded
- Skin irritation. Skin irritation is common with adapalene and benzoyl peroxide gel and is most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of adapalene and benzoyl peroxide gel. Skin reactions at the treatment area include redness, scaling, dryness, stinging, burning, itching and swelling. Tell your doctor if you get any skin reactions.
- Sensitivity to sunlight. See “What should I avoid while using adapalene and benzoyl peroxide gel?”
These are not all of the possible side effects of adapalene and benzoyl peroxide gel.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store adapalene and benzoyl peroxide gel?
- Store adapalene and benzoyl peroxide gel at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep adapalene and benzoyl peroxide gel out of light and away from heat.
Keep adapalene and benzoyl peroxide gel and all medicines out of the reach of children.
General information about the safe and effective use of adapalene and benzoyl peroxide gel.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use adapalene and benzoyl peroxide gel for a condition for which it was not prescribed. Do not give adapalene and benzoyl peroxide gel to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about adapalene and benzoyl peroxide gel that is written for health professionals.
What are the ingredients in adapalene and benzoyl peroxide gel?
Active ingredient: adapalene and benzoyl peroxide
Inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Issued: April 2026