epiduo forte 3 mg/g

adapalene and benzoyl peroxide · GEL · Galderma Laboratories, L.P.

No Recall History

Plain English

epiduo forte is a gel containing adapalene and benzoyl peroxide at 3 mg/g, taken topical. Manufactured by Galderma Laboratories, L.P..

Key Facts

Brand Name: epiduo forte
Generic Name: adapalene and benzoyl peroxide
NDC Code (Product): 0299-5906
Manufacturer: Galderma Laboratories, L.P.
Strength: 3 mg/g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: NDA207917
Drug Class: Retinoid [EPC]
Marketing Start: 07/01/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

erythema78 reports

skin burning sensation78 reports

dry skin64 reports

drug ineffective59 reports

acne44 reports

skin irritation44 reports

skin exfoliation40 reports

pruritus34 reports

pain of skin33 reports

rash33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. EPIDUO FORTE, is a combination of adapalene, a retinoid, and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For topical use only. EPIDUO FORTE is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of EPIDUO FORTE to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Wash hands after application as EPIDUO FORTE may bleach hair or colored fabrics. Avoid the eyes, lips and mucous membranes. For topical use only EPIDUO FORTE is not for oral, ophthalmic or intravaginal use. ( 2 ) Apply a thin layer of EPIDUO FORTE to affected areas of the face and/or trunk once daily after washing. ( 2 ) Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). ( 2 ) Avoid the eyes, lips, and mucous membranes. ( 2 )

Contraindications

4 CONTRAINDICATIONS EPIDUO FORTE is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPIDUO FORTE. EPIDUO FORTE is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPIDUO FORTE. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions ( 5.1 ) ] Skin Irritation/Contact Dermatitis [ see Warnings and Precautions ( 5.3 ) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During the randomized, double-blind, vehicle- and active-controlled clinical trial, 217 subjects were exposed to EPIDUO FORTE. A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with EPIDUO FORTE and for which the rate with EPIDUO FORTE exc…

Frequently Asked Questions

What is epiduo forte used for?

epiduo forte contains adapalene and benzoyl peroxide. It is a gel taken topical. Consult your doctor for specific uses.

Is epiduo forte a controlled substance?

epiduo forte is not classified as a controlled substance by the DEA.

What is the generic name for epiduo forte?

The generic name for epiduo forte is adapalene and benzoyl peroxide. There are 11 other brand versions of adapalene and benzoyl peroxide.

What is the NDC code for epiduo forte 3 mg/g?

The NDC (National Drug Code) for epiduo forte 3 mg/g is 0299-5906, listed by Galderma Laboratories, L.P..

Product NDC

0299-5906

Package NDC

0299-5906-00

Other Adapalene Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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