Adapalene and Benzoyl Peroxide

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For topical use only;
• Adapalene and benzoyl peroxide gel is not for oral, ophthalmic, or intravaginal use.
• Apply a thin film of adapalene and benzoyl peroxide gel 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 is not for oral, ophthalmic, or intravaginal use.
• ( 2 ) Apply a thin film of adapalene and benzoyl peroxide gel 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 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

Safety and effectiveness of adapalene and benzoyl peroxide gel in pediatric patients under the age of 9 have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of adapalene and benzoyl peroxide gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Most commonly reported adverse events (≥1%) in patients treated with adapalene and benzoyl peroxide gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical Studies Experience 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 clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel.
• 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 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 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 or with the vehicle gel once daily for 12 weeks.
• Overall, the safety profile of adapalene and benzoyl peroxide gel 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 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 postapproval use of adapalene and benzoyl peroxide gel:
• 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• [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 adapalene and benzoyl peroxide 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. - Adapalene and benzoyl peroxide 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. - Adapalene and benzoyl peroxide gel may bleach hair and colored fabric.
• Distributed by:
• Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com May 2025 logo1

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Each gram of adapalene and benzoyl peroxide gel contains 1 mg (0.1%) adapalene, USP and 25 mg (2.5%) benzoyl peroxide, USP in a white to pale yellow, opaque gel.
• Each gram of adapalene and benzoyl peroxide gel contains 1 mg (0.1%) adapalene, USP and 25 mg (2.5%) benzoyl peroxide, USP.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is white to pale yellow in color and opaque in appearance, and is supplied as follows:
• 45 gram tube NDC 68462-301-55 45 gram pump NDC 68462-301-47
• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
• Protect from light.
• Keep out of reach of children.
• Keep away from heat.
• Keep tube tightly closed.

Quoted from the official label, section “How Supplied”.

What is in it

• Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to pale yellow, opaque gel for topical use containing adapalene, USP, 0.1%, and benzoyl peroxide, USP, 2.5%.
• Adapalene, USP a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties.
• The chemical name for adapalene, USP is 6-(4-Methoxy-3-(tricyclo [3.3.1.13,7 ]dec-1-ylphenyl)-2-naphthalene carboxylic acid .
• It has the following structural formula:
• Adapalene, USP:
• Molecular formula:
• C 28 H 28 O 3 Molecular weight:
• 412.52 g/mol Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes.
• The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide.
• It has the following structural formula:
• Benzoyl Peroxide, USP:
• Molecular formula:
• C 14 H 10 O 4 Molecular weight:
• 242.23 g/mol Adapalene and Benzoyl Peroxide Gel contains the following inactive ingredients:
• carbomer homopolymer type C, cyclomethicone, docusate sodium, edetate disodium, glycerin, propylene glycol, poloxamer 124, purified water, sorbitan oleate and sodium hydroxide. adapalenestructure benzoylperoxidestructure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

14 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Adapalene and Benzoyl Peroxide