epiduo forte adapalene and benzoyl peroxide

Get an overview of EPIDUO FORTE (adapalene and benzoyl peroxide gel), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in epiduo forte can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as epiduo forte.

Drug Basics

Brand Name: epiduo forte

Generic Name: ADAPALENE AND BENZOYL PEROXIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form: GEL

Packager: Galderma Laboratories, L.P.

Data Current As Of: 2021-10-11

Indications & Usage

EPIDUO FORTE gel is indicated for the topical treatment of acne vulgaris.x

EPIDUO FORTE gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris.

Drug Interactions

No formal drug-drug interaction studies were conducted with EPIDUO FORTE gel.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

Patient Counseling Information

[See FDA Approved Patient Labeling (Patient Information)]

Information for Patients
Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO FORTE gel as a thin layer, avoiding the eyes, lips and mucous membranes.
Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation.
EPIDUO FORTE gel may cause irritation such as erythema, scaling, dryness, stinging or burning.
Advise patients to minimize exposure to sunlight, including sunlamps.
Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
EPIDUO FORTE gel may bleach hair and colored fabric.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Made in Canada
All trademarks are the property of their respective owners.
P52751-1

Label 45g Carton

P52750 2 carton Epiduo Forte.jpg

Rx only NDC 0299-5906-45

EPIDUO® FORTE

(adapalene and benzoyl peroxide) 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

P52750-2

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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