EPSOLAY (Page 3 of 3)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity
Inform patients that serious hypersensitivity reactions occurred with the use of benzoyl peroxide products. If a patient experiences a serious hypersensitivity reaction, instruct patient to discontinue EPSOLAY immediately and seek medical help [ see Warnings and Precautions (5.1)].
Skin Irritation/Contact Dermatitis
Inform patients that EPSOLAY may cause irritation such as erythema, scaling, dryness, stinging or burning. Advise the patient to use a moisturizer for irritation [see Warnings and Precautions (5.2)].
Photosensitivity
Advise patients to minimize or avoid exposure to natural or artificial light (tanning beds or UVA/B treatment) and to use sun protective measures, if patients need to be outdoors while using EPSOLAY [see Warnings and Precautions (5.3)].
Administration Instructions
Advise patients to apply EPSOLAY exactly as directed in a thin layer, avoiding the eyes, lips and mouth and to wash hands immediately after application. Inform patients that EPSOLAY may bleach hair or colored fabric [see Dosage and Administration (2)].

Marketed by: GALDERMA LABORATORIES, L.P.
Dallas, TX 75201 USA
Made in Canada
All trademarks are the property of their respective owners.
P57267-1

PATIENT INFORMATION

EPSOLAY® (ep’ soe lay)
(benzoyl peroxide) cream

Important: EPSOLAY is for use on the skin only (topical). Do not use EPSOLAY in or on your mouth, eyes or vagina.

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.

Marketed by GALDERMA LABORATORIES, L.P., Dallas, TX 75201 USA
Made in Canada
All trademarks are the property of their respective owners.
P57267-1
For more information, go to www.EPSOLAY.com or call GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 4/2023

PRINCIPAL DISPLAY PANEL — 30 g Pump Carton

30g-carton-image
(click image for full-size original)

Rx Only
NDC 0299-5890-30

EPSOLAY®
(benzoyl peroxide) cream, 5%

For topical use only.
Not for ophthalmic, oral,
or intravaginal use.

Package is not child-resistant.
Keep out of reach of children.

30g Pump

P57494-0

EPSOLAY benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5890
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Anhydrous Citric Acid
Cetrimonium Chloride
Cetyl Alcohol
Cyclomethicone
Edetate Disodium
Glycerin
Glyceryl Mono And Dipalmitostearate
Hydrochloric Acid
Lactic Acid, Unspecified Form
Peg-100 Stearate
Phenoxyethanol
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw)
Silicon Dioxide
Sodium Hydroxide
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5890-30 1 BOTTLE, PUMP in 1 BOX contains a BOTTLE, PUMP
1 30 g in 1 BOTTLE, PUMP This package is contained within the BOX (0299-5890-30)
2 NDC:0299-5890-00 3 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214510 05/09/2022
Labeler — Galderma Laboratories, L.P. (047350186)
Registrant — Galderma Laboratories, L.P. (047350186)

Revised: 04/2023 Galderma Laboratories, L.P.

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