Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% · GEL · Encube Ethicals, Inc.
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a gel containing adapalene and benzoyl peroxide gel, 0.1%/2.5% at 1 mg/g, taken topical. Manufactured by Encube Ethicals, Inc..
Key Facts
- Brand Name
- Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
- Generic Name
- Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
- NDC Code (Product)
21922-052- Manufacturer
- Encube Ethicals, Inc.
- Strength
- 1 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA206164
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 08/14/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 Gel, 0.1%/2.5% used for?
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. It is a gel taken topical. Consult your doctor for specific uses.
Is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% a controlled substance?
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not classified as a controlled substance by the DEA.
What is the generic name for Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?
The generic name for Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. There are no other listed brand versions of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.
What is the NDC code for Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g?
The NDC (National Drug Code) for Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g is 21922-052, listed by Encube Ethicals, Inc..
Other Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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