Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is an FDA-registered drug product whose active ingredient is ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5%. It is labelled by Encube Ethicals, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 21922-052, application ANDA206164, label effective 20260615. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5% are most often described in connection with: benzoyl peroxide, gel usp, topical treatment, acne vulgaris, patients years, usage adapalene. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Adapalene and benzoyl peroxide gel USP, 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 USP, 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)

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)

4 CONTRAINDICATIONS None None. (4)

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 Clinical Trials by At Least 1% of Patients Treated For 12 Weeks System Organ Class/Preferred Term Adapalene and Benzoyl Peroxide Gel 0.1% / 2.5% N=564 Vehicle gel N=489 Subjects with AE (s) 14% 4% Dry Skin 7% 2% Contact dermatitis 3% <1% Application site burning 2% <1% Application site irritation 1% <1% Skin irritation 1% 0% Local tolerability evaluations, presented in Table 2 , were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging. Table 2. Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N=553) Treatment Emergent Signs and Symptoms Maximum Severity During Treatment End of Treatment Severity (12 Weeks) Mild Moderate Severe Mild Moderate Severe Erythema 27% 13% 1% 8% 2% 1% Scaling 35% 11% 1% 9% 1% <1% Dryness 41% 13% 1% 10% 2% <1% Stinging/burning 41% 15% 3% 7% 2% 1% Analysis over the 12 week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter. During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with adapalene and benzoyl peroxide gel 0.1% / 2.5% or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of adapalene and benzoyl peroxide gel 0.1% / 2.5% in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed adverse events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of adapalene and benzoyl peroxide gel 0.1% / 2.5%: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

What is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% used for?
1 INDICATIONS AND USAGE Adapalene and benzoyl peroxide gel USP, 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 USP, 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)

Who makes Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?
Encube Ethicals, Inc. is the labeler of record for Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

What form does Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.