Important Safety Information - Adapalene / Benzoyl Peroxide

Written by HeyDoctor Medical Team

Important safety information and consumer warnings you should know about adapalene / benzoyl peroxide.

Overview

The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Adapalene / Benzoyl Peroxide (EpiDuo)

Important: For use on the skin only (topical). Do not use Adapalene / Benzoyl Peroxide in or on your mouth, eyes, or vagina.

Read this Patient Information leaflet about Adapalene / Benzoyl Peroxide before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about Adapalene / Benzoyl Peroxide, talk with your doctor or pharmacist.

What is Adapalene / Benzoyl Peroxide?

Adapalene / Benzoyl Peroxide is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older.

Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if Adapalene / Benzoyl Peroxide is safe and effective in children younger than 9 years old.

What should I tell my doctor before using Adapalene / Benzoyl Peroxide?

Before you use Adapalene / Benzoyl Peroxide, tell your doctor if you:

  • have other skin problems, including cuts or sunburn
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if Adapalene / Benzoyl Peroxide can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Adapalene / 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 / Benzoyl Peroxide.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Especially tell your doctor if you use any other medicine for acne. Using Adapalene / Benzoyl Peroxide with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Adapalene / Benzoyl Peroxide?

  • Use Adapalene / Benzoyl Peroxide exactly as your doctor tells you to use it. Adapalene / Benzoyl Peroxide is for skin use only. Do not use Adapalene / Benzoyl Peroxide in or on your mouth, eyes, or vagina.
  • Apply Adapalene / Benzoyl Peroxide 1 time a day.
  • Do not use more Adapalene / Benzoyl Peroxide than you need to cover the treatment area. Using too much Adapalene / Benzoyl Peroxide or using it more than 1 time a day may increase your chance of skin irritation.

Applying Adapalene / Benzoyl Peroxide:

Wash the area where the will be applied with a mild cleanser and pat dry. x Adapalene / Benzoyl Peroxide comes in a tube and a pump. If you have been prescribed the:

  • Tube: Squeeze a small amount (about the size of a pea) of Adapalene / Benzoyl Peroxide onto your fingertips and spread a thin layer over the affected area.
  • Pump: Depress the pump to dispense a small amount (about the size of a pea) of Adapalene / Benzoyl Peroxide and spread a thin layer over the affected area.

What should I avoid while using Adapalene / Benzoyl Peroxide?

  • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene / Benzoyl Peroxide can make your skin sensitive to the sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with Adapalene / Benzoyl Peroxide if you have to be in sunlight.
  • You should avoid weather extremes such as wind and cold as this may cause irritation to your skin.
  • You should avoid applying Adapalene / Benzoyl Peroxide to cuts, abrasions and sunburned skin. x You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol.
  • You should avoid the use of “waxing” as a hair removal method on skin treated with Adapalene / Benzoyl Peroxide.
  • Adapalene / Benzoyl Peroxide may bleach your clothes or hair. Allow Adapalene / Benzoyl Peroxide to dry completely before dressing to prevent bleaching of your clothes.

What are the possible side effects of Adapalene / Benzoyl Peroxide?

Adapalene / Benzoyl Peroxide may cause serious side effects including:

Local skin reactions

Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of Adapalene / Benzoyl Peroxide.

Signs and symptoms of local skin reaction include:
  • Redness
  • Dryness
  • Swelling
  • Scaling
  • Stinging or burning

Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using Adapalene / Benzoyl Peroxide.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adapalene / Benzoyl Peroxide. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

How should I store Adapalene / Benzoyl Peroxide?

  • Store Adapalene / Benzoyl Peroxide at room temperature, 68° – 77° F (20° – 25° C)
  • Keep Adapalene / Benzoyl Peroxide inside container and out of light and away from heat.
  • Keep Adapalene / Benzoyl Peroxide and all medicines out of the reach of children.

General information about Adapalene / Benzoyl Peroxide

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Adapalene / Benzoyl Peroxide for a condition for which it was not prescribed. Do not give Adapalene / Benzoyl Peroxide to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Adapalene / Benzoyl Peroxide. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Adapalene / Benzoyl Peroxide that is written for health professionals.

What are the ingredients in Adapalene / Benzoyl Peroxide?

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
  • sorbitan oleate
The views expressed in this article intend to highlight alternative studies and induce conversation. They are the views of the author and do not necessarily represent the views of HeyDoctor, and are for informational purposes only, even if and to the extent that this article features the advice of physicians and medical practitioners. This article is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment, and should never be relied upon for specific medical advice.

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