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Epsolay: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
30 mg/g
Active ingredient:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Epsolay

What is EPSOLAY?

EPSOLAY is a prescription medicine used on the skin (topical) to treat adults with pimples and bumps caused by a condition called rosacea.

It is not known if EPSOLAY is safe and effective in children.

Do not use EPSOLAY if you have had an allergic reaction to benzoyl peroxide or any of the ingredients in EPSOLAY. See the end of this leaflet for a complete list of ingredients in EPSOLAY.

Before using EPSOLAY, tell your healthcare provider about all of your medical conditions, including if you:

  • have other skin problems, including eczema, cuts, or sunburn.

  • are pregnant or plan to become pregnant. It is not known if EPSOLAY will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if EPSOLAY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with EPSOLAY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use EPSOLAY?

  • Use EPSOLAY exactly as your healthcare provider tells you.
  • Apply EPSOLAY to your face 1 time each day on clean and dry skin.
  • Before you use EPSOLAY for the first time, prime the pump by pressing down until the first drop of cream is released.
  • Use the pump to dispense a pea-size amount of EPSOLAY onto your fingertip. Spread a thin layer over each area of your face (forehead, chin, nose, each cheek). Avoid contact with your eyes, lips and mouth.
  • Wash your hands right away after applying EPSOLAY.

What should I avoid while using EPSOLAY?

  • Avoid using EPSOLAY on skin areas with cuts, abrasions, eczema, or on sunburned skin.
  • Limit your time in sunlight. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. EPSOLAY may make your skin more sensitive to the sun and the light from sunlamps and tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using EPSOLAY if you get sunburn.
  • Avoid getting EPSOLAY in your hair or on colored fabric. EPSOLAY may bleach hair or colored fabric.

What are the possible side effects of EPSOLAY?

EPSOLAY may cause serious side effects, including:

  • Allergic reactions. Stop using EPSOLAY and get medical help right away if you have any of the following symptoms during treatment with EPSOLAY:

    • 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. EPSOLAY may cause skin irritation such as redness, scaling, dryness, stinging, or burning. You may use a moisturizer if you develop skin irritation. Tell your healthcare provider if your symptoms do not improve, you may need to stop treatment with EPSOLAY.
  • Sensitivity to sunlight. See "What should I avoid while using EPSOLAY?"

The most common side effects of EPSOLAY include pain, redness, itching, and swelling at application site.

These are not all the possible side effects with EPSOLAY.

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 EPSOLAY?

  • Store EPSOLAY at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep EPSOLAY away from heat.
  • Do not freeze EPSOLAY
  • Throw away (discard) unused EPSOLAY 60 days after first use.

Keep EPSOLAY and all medicines out of the reach of children.

General information about the safe and effective use of EPSOLAY.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPSOLAY for a condition for which it was not prescribed. Do not give EPSOLAY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EPSOLAY that is written for health professionals.

What are the ingredients in EPSOLAY?

Active ingredient: benzoyl peroxide

Inactive ingredients: anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide.

Distributed by:

Mayne Pharma

Raleigh, NC 27609

Product of Canada

EPSOLAY is a registered trademark of Mayne Pharma LLC.

IN-51862-772-30

For more information, go to www.EPSOLAY.com or call Mayne Pharma at 1-844-825-8500.

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 02/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 214510 · View the label on DailyMed

Revision date stated in the text: February 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Epsolay

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Benzoyl peroxide 30 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) MAYNE PHARMA
FDA approval NDA 214510New Drug Application (NDA) Approved April 22, 2022
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
30 mg/g – 30 g in 1 bottle, pump / 1 in 1 carton NDC 51862-772-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.