Drugplain

adapalene and benzoyl peroxide 3 mg/g

adapalene and benzoyl peroxide · GEL · Mayne Pharma Inc.

1 Recall on Record
Plain English

adapalene and benzoyl peroxide is a gel containing adapalene and benzoyl peroxide at 3 mg/g, taken topical. Manufactured by Mayne Pharma Inc..

Key Facts

Brand Name
adapalene and benzoyl peroxide
Generic Name
adapalene and benzoyl peroxide
NDC Code (Product)
68308-662
Manufacturer
Mayne Pharma Inc.
Strength
3 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
NDA207917
Drug Class
Retinoid [EPC]
Marketing Start
02/01/2022

Recall History

1 Recall on Record
Class II02/12/2024

MCKESSON CORPORATION

CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective10 reports
rash8 reports
acne5 reports
application site pain4 reports
erythema4 reports
application site erythema3 reports
application site pruritus3 reports
burning sensation3 reports
skin burning sensation3 reports
application site irritation2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For topical use only; adapalene and benzoyl peroxide gel 0.1% / 2.5% is not for oral, ophthalmic, or intravaginal use. Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% 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). Avoid the eyes, lips and mucous membranes. Adapalene and benzoyl peroxide gel 0.1% / 2.5% is not for oral, ophthalmic, or intravaginal use. (2) Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% 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). Avoid the eyes, lips and mucous membranes. (2)

Contraindications

4 CONTRAINDICATIONS None None. (4)

Drug Interactions

7 DRUG INTERACTIONS 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. No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel 0.1% / 2.5%.

Adverse Reactions

6 ADVERSE REACTIONS Most commonly reported adverse events (≥1%) in patients treated with adapalene and benzoyl peroxide gel 0.1% / 2.5% were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited, at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel 0.1% / 2.5%. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with adapalene and benzoyl peroxide gel 0.1% / 2.5% and those reported in subjects treated with the vehicle gel are presented in Table 1 : Table 1. Drug Related Adverse Events Reported in C…

Frequently Asked Questions

What is adapalene and benzoyl peroxide used for?

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

Is adapalene and benzoyl peroxide a controlled substance?

adapalene and benzoyl peroxide is not classified as a controlled substance by the DEA.

What is the generic name for adapalene and benzoyl peroxide?

The generic name for adapalene and benzoyl peroxide is adapalene and benzoyl peroxide. There are 9 other brand versions of adapalene and benzoyl peroxide.

What is the NDC code for adapalene and benzoyl peroxide 3 mg/g?

The NDC (National Drug Code) for adapalene and benzoyl peroxide 3 mg/g is 68308-662, listed by Mayne Pharma Inc..

Product NDC

68308-662

Package NDC

68308-662-45

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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