Epiduo Forte (Page 4 of 4)

Patient Information

EPIDUO FORTE (Ep-E-Do-Oh For-Tay)
(adapalene and benzoyl peroxide)
topical gel

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

What is EPIDUO FORTE?
EPIDUO FORTE is a prescription medicine used on the skin (topical) to treat acne vulgaris. It is not known whether EPIDUO FORTE is safe and effective in children under 12 years of age.

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

Before using EPIDUO FORTE, 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 EPIDUO FORTE can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if EPIDUO FORTE 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 EPIDUO FORTE. If you use EPIDUO FORTE while breastfeeding, use EPIDUO FORTE on the smallest area of the skin and for the shortest time needed. Do not apply EPIDUO FORTE 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 EPIDUO FORTE?

  • Use EPIDUO FORTE exactly as your doctor tells you to use it.
  • Apply EPIDUO FORTE 1 time a day.
  • Do not use more EPIDUO FORTE than you need to cover the treatment area. Using too much EPIDUO FORTE or using it more than 1 time a day may increase your chance of skin irritation.

Applying EPIDUO FORTE:

  • Wash the area where the gel will be applied with a mild or soapless cleanser and pat dry.
  • EPIDUO FORTE comes in a pump. Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO FORTE 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. EPIDUO FORTE may bleach your hair or colored fabrics. Allow EPIDUO FORTE to dry completely before dressing to prevent bleaching of your clothes.

What should I avoid while using EPIDUO FORTE?

  • Avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO FORTE 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 EPIDUO FORTE if you have to be in sunlight.
  • Cold weather and wind may irritate skin treated with EPIDUO FORTE.
  • Avoid applying EPIDUO FORTE 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 EPIDUO FORTE.

What are the possible side effects of EPIDUO FORTE?
EPIDUO FORTE may cause serious side effects including:

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

    • 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 EPIDUO FORTE and is most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of EPIDUO FORTE. 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 EPIDUO FORTE?”

These are not all of the possible side effects of EPIDUO FORTE.
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 EPIDUO FORTE?

  • Store EPIDUO FORTE at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep EPIDUO FORTE out of light and away from heat.

Keep EPIDUO FORTE and all medicines out of the reach of children.

General information about the safe and effective use of EPIDUO FORTE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPIDUO FORTE for a condition for which it was not prescribed. Do not give EPIDUO FORTE 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 EPIDUO FORTE that is written for health professionals.

What are the ingredients in EPIDUO FORTE?

Active ingredient: adapalene and benzoyl peroxide

Inactive ingredients: acrylamide/sodium acryloydimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, polaxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate

Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Made in Canada
All trademarks are the property of their respective owners.
For more information, call GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 04/2022

LABEL — 45g Carton

45-gram-carton-image
(click image for full-size original)

Rx only NDC 0299-5906-45

EPIDUO® FORTE

(adapalene and benzoyl peroxide) Topical Gel 0.3%/2.5%

PUMP

FOR TOPICAL USE ONLY

NET WT.

45 g

GALDERMA

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

Usual dosage: Apply a thin layer once a day to affected areas. See package insert for complete prescribing information.

Each gram contains: Active: adapalene 0.3% and benzoyl peroxide 2.5% in a gel. Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C).

See carton closure for lot number and expiration date.

Marketed by:

GALDERMA LABORATORIES, L.P.

14501 North Freeway

Fort Worth, Texas 76177 USA

Made in Canada.

All trademarks are the property of their respective owners

www.epiduoforte.com

P52750-X

EPIDUO FORTE adapalene and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5906
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE (ADAPALENE) ADAPALENE 3 mg in 1 g
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)
DOCUSATE SODIUM
EDETATE DISODIUM
GLYCERIN
ISOHEXADECANE
POLOXAMER 124
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SORBITAN MONOOLEATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5906-15 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 15 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5906-15)
2 NDC:0299-5906-30 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5906-30)
3 NDC:0299-5906-45 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
3 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5906-45)
4 NDC:0299-5906-60 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
4 60 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5906-60)
5 NDC:0299-5906-70 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
5 70 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5906-70)
6 NDC:0299-5906-05 1 TUBE in 1 BLISTER PACK contains a TUBE
6 5 g in 1 TUBE This package is contained within the BLISTER PACK (0299-5906-05)
7 NDC:0299-5906-02 1 TUBE in 1 BLISTER PACK contains a TUBE
7 2 g in 1 TUBE This package is contained within the BLISTER PACK (0299-5906-02)
8 NDC:0299-5906-00 2 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207917 07/01/2015
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (0299-5906)

Revised: 04/2022 Galderma Laboratories, L.P.

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