Medicine guide

Adapalene and Benzoyl Peroxide

3 mg/g + 25 mg/g · Gel

Prescription only
Retinoid

Active substance: Adapalene and Benzoyl Peroxide
Used in: Skin
Made by: Viona Pharmaceuticals Inc
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-06-13

What it is

Retinoid

Used for

Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in

Do not take it if

Adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

13other products contain Adapalene and Benzoyl Peroxide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in
adults and pediatric patients 12 years of age and older.
Adapalene and benzoyl peroxide gel, 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 )

From the official label · 2025-06-13 · DailyMed

How it works

From this product’s own US prescribing label.

Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein.
Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes.

How it leaves the body

Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-06-13

Do not take it if

Adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel.
Adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel.
( 4 )

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 layer 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).
Wash hands after application as adapalene and benzoyl peroxide gel may bleach hair or colored fabrics.
Avoid the eyes, lips and mucous membranes.
For topical use only Adapalene and benzoyl peroxide gel is not for oral, ophthalmic or intravaginal use.
( 2 ) Apply a thin layer of adapalene and benzoyl peroxide gel 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 )

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

Other warnings

Hypersensitivity:
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products.
( 5.1 ) Photosensitivity: Avoid exposure to sunlight and sunlamps.
Wear broad spectrum sunscreen and protective clothing when sun exposure cannot be avoided.
( 5.2 ) Skin Irritation:
Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of adapalene and benzoyl peroxide gel and may necessitate discontinuation.
( 5.3 )
5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products.
If a serious hypersensitivity reaction occurs, discontinue adapalene and benzoyl peroxide gel immediately and initiate appropriate therapy.
Photosensitivity
Avoid exposure to sunlight, including sunlamps, during the use of adapalene and benzoyl peroxide gel.
Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution.
Use of broad spectrum sunscreen products and protective apparel (e.g., hat) are recommended when exposure cannot be avoided.
Weather extremes, such as wind or cold, may be irritating to patients under treatment with adapalene and benzoyl peroxide gel.
5.3 Skin Irritation/Contact Dermatitis Erythema, scaling, dryness and stinging/burning may be experienced with use of adapalene and benzoyl peroxide gel.
These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity and usually lessen with continued use of the medication.
Irritant and allergic contact dermatitis may occur.
Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of adapalene and benzoyl peroxide gel or discontinue use.
The product should not be applied to cuts, abrasions, eczematous or sunburned skin.
As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene and benzoyl peroxide gel.
Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices or limes).

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Available pharmacovigilance data with adapalene and benzoyl peroxide gel use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Animal reproduction studies have not been conducted with the combination gel.
Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data).
Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown.
Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Hence, maternal use is not expected to result in fetal exposure of the drug.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 mg/kg/day to 5 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide gel based on a mg/m 2 comparison.
However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (41 and 81 times the MRHD, respectively, based on a mg/m 2 comparison).
Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.
Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
Risk Summary Adapalene gel, 0.3% There are no data on the presence of adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
In animal studies, adapalene is present in rat milk with oral administration of the drug.
When a drug is present in animal milk, it is likely that the drug will be present in human milk.
It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations).
Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown.
Based on the published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases.
There are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene and benzoyl peroxide gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide gel or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide gel on
the smallest area of skin and for the shortest duration possible while breastfeeding.
Advise breastfeeding women not to apply adapalene and benzoyl peroxide gel directly to the nipple and areola to
avoid direct infant exposure.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary Available pharmacovigilance data with adapalene and benzoyl peroxide gel use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Animal reproduction studies have not been conducted with the combination gel.
Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data).
Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown.
Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Hence, maternal use is not expected to result in fetal exposure of the drug.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 mg/kg/day to 5 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide gel based on a mg/m 2 comparison.
However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (41 and 81 times the MRHD, respectively, based on a mg/m 2 comparison).
Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.
Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
8.2 Lactation Risk Summary Adapalene gel, 0.3% There are no data on the presence of adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
In animal studies, adapalene is present in rat milk with oral administration of the drug.
When a drug is present in animal milk, it is likely that the drug will be present in human milk.
It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations).
Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown.
Based on the published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases.
There are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene and benzoyl peroxide gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide gel or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide gel on
the smallest area of skin and for the shortest duration possible while breastfeeding.
Advise breastfeeding women not to apply adapalene and benzoyl peroxide gel directly to the nipple and areola to
avoid direct infant exposure.
8.4 Pediatric Use Safety and effectiveness of adapalene and benzoyl peroxide gel in pediatric patients under the age of 12 have not been established.
8.5 Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

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

Use in children

Safety and effectiveness of adapalene and benzoyl peroxide gel in pediatric patients under the age of 12 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 years and over to determine whether they respond differently from younger subjects.

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

Side effects

The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 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 adapalene and benzoyl peroxide gel.
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 adapalene and benzoyl peroxide gel and for which the rate with adapalene and benzoyl peroxide gel exceeded the rate for the vehicle are presented in Table 1:
Table 1 Adverse Reactions Occurring in ≥ 1% of Subjects with Acne Vulgaris in a 12 week Clinical Trial Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) Vehicle (N=69) Skin irritation 4% < 1% 0% Eczema 1% 0% 0% Dermatitis atopic 1% 0% 0% Skin burning sensation 1% 0% 0% Local tolerability evaluations presented in Table 2, were conducted at each trial visit in the clinical trial by assessment of erythema, scaling, dryness and stinging/burning, which peaked at Week 1 of therapy and decreased thereafter.
Table 2 Incidence of Local Cutaneous Irritation in 12 week Clinical Trial in Subjects with Acne Vulgaris Maximum Severity During Treatment End of Treatment Severity (Final Score) Moderate Severe Moderate Severe Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% (N=213) Erythema 20% 1% 4% < 1% Scaling 17% 1% 1% < 1% Dryness 15% 2% 3% < 1% Stinging/burning 19% 6% 1% 1% Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212) Erythema 15% 1% 2% < 1% Scaling 12% < 1% 2% 0% Dryness 13% 1% 2% 0% Stinging/burning 14% 9% 3% 0% Vehicle (N=68) Erythema 6% 1% 1% 0% Scaling 6% 0% 1% 0% Dryness 4% 1% 1% 0% Stinging/burning 3% 1% 0% 0%
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of adapalene and benzoyl peroxide gel.
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.
Skin and subcutaneous tissue disorders:
sunburn, blister (including vesicles and bullae), pruritus, hyperpigmentation and hypopigmentation.

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

What to discuss with your doctor

Advise the patient to read the FDA approved patient labeling (Patient Information).
Hypersensitivity Inform patients that serious hypersensitivity reactions occurred with the use of benzoyl peroxide products.
If a patient experiences a serious hypersensitivity reaction, instruct patient to discontinue adapalene and benzoyl peroxide gel immediately and seek medical help [see Warnings and Precautions ( 5.1 )] .
Photosensitivity Advise patients to minimize or
avoid exposure to natural or artificial light, including tanning beds or UVA/B treatment.
Recommend the use of broad spectrum sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided [see Warnings and Precautions ( 5.2 )] .
Skin Irritation/Contact Dermatitis Inform patients that adapalene and benzoyl peroxide gel may cause irritation such as erythema, scaling, dryness, stinging or burning [see Warnings and Precautions ( 5.3 )] .
Lactation Use adapalene and benzoyl peroxide gel on
the smallest part of the skin and for the shortest duration possible while breastfeeding.
Advise breastfeeding women not to apply adapalene and benzoyl peroxide gel directly to the nipple and areola to
avoid direct infant exposure [see Use in Specific Populations ( 8.2 )] .
Administration Instructions 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.
Wash hands after application as adapalene and benzoyl peroxide gel may bleach hair and colored fabric.

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

Strengths and forms

FORMS AND STRENGTHS Each gram of adapalene and benzoyl peroxide gel, USP contains 3 mg (0.3%) adapalene, USP and 25 mg (2.5%) benzoyl peroxide, USP in a white to very pale yellow opaque gel.
Adapalene and benzoyl peroxide gel, USP is available in pumps containing 45 g or 60 g.
Topical Gel, 0.3%/2.5%.
( 3 )

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

What it looks like and how it is packed

16.1 How Supplied Adapalene and benzoyl peroxide gel, USP 0.3%/2.5% is white to very pale yellow in color and opaque in appearance and is supplied as follows:
45 gram pump NDC 72578-119-04 60 gram pump NDC 72578-119-02
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Keep away from heat.
Protect from light.
Keep out of reach of children.

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

What is in it

Adapalene and benzoyl peroxide gel 0.3%/2.5% is a white to very pale yellow opaque gel for topical use containing adapalene, USP 0.3% and benzoyl peroxide 2.5%.
Adapalene USP, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties.
The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid).
It has the following structural formula:
Adapalene:
Molecular formula:
C 28 H 28 O 3 Molecular weight:
412.5 Hydrous benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes.
The chemical name for benzoyl peroxide is dibenzoyl peroxide.
It has the following structural formula:
Benzoyl Peroxide:
Molecular formula:
C 14 H 10 O 4 Molecular weight:
242.23 Adapalene and benzoyl peroxide gel, USP contains the following inactive ingredients:
acrylamide/sodium acryloyldimethyl taurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan monooleate.
Image Image

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.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (9)

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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.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (6)

Details

Made by	Viona Pharmaceuticals Inc
Active substance	Adapalene and Benzoyl Peroxide
Used in	Skin
Strength	3 mg/g + 25 mg/g
Form	Gel
Route	Topical
Packs	1 BOTTLE, PUMP in 1 BOTTLE, PUMP / 60 g in 1 BOTTLE, PUMP · 1 BOTTLE, PUMP in 1 BOTTLE, PUMP / 45 g in 1 BOTTLE, PUMP
NDC	72578-119

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.

Gel14 products
- .1 g/100g + 2.5 g/100g2
  .1 g/100g + 2.5 g/100g · 2 companies
  - Bryant Ranch Prepack
  - Padagis Israel Pharmaceuticals Ltd
- 1 mg/g + 25 mg/g2
  1 mg/g + 25 mg/g · 2 companies
  - Glenmark Pharmaceuticals Inc., USA
  - Sun Pharmaceutical Industries, Inc.
- 3 mg/g + 25 mg/g10
  3 mg/g + 25 mg/g · 10 companies
  +2 more

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