Mediclarum
Medicine guide

Adapalene and Benzoyl Peroxide

3 mg/g + 25 mg/g · Gel

  • Prescription only
  • Retinoid
Used in
Skin
Made by
Alembic Pharmaceuticals Inc.

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 · 2025-05-21

What it is

Retinoid

Used for
  • Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in
Do not take it if

Adapalene and benzoyl peroxide topical 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 topical 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
1other products contain Adapalene and Benzoyl Peroxide Topical — 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 topical 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 topical 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 · 2025-05-21 · 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 · 2025-05-21

Do not take it if

  • Adapalene and benzoyl peroxide topical 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 topical gel.
  • Adapalene and benzoyl peroxide topical 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 topical 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 topical gel is not for oral, ophthalmic, or intravaginal use.
  • Apply a thin layer of adapalene and benzoyl peroxide topical 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 topical gel may bleach hair or colored fabrics.
  • Avoid the eyes, lips and mucous membranes.
  • For topical use only Adapalene and benzoyl peroxide topical gel is not for oral, ophthalmic or intravaginal use.
  • ( 2 ) Apply a thin layer of adapalene and benzoyl peroxide topical 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 topical 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 topical gel immediately and initiate appropriate therapy.
  • Photosensitivity
  • Avoid exposure to sunlight, including sunlamps, during the use of adapalene and benzoyl peroxide topical 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 topical gel.
  • 5.3 Skin Irritation and Contact Dermatitis Erythema, scaling, dryness, and stinging/burning may be experienced with use of adapalene and benzoyl peroxide topical 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 topical 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 topical 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 topical 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 to 5.0 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide topical 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 6.0 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 Sumary Adapalene gel, 0.3% There are no data on the presence of adapalene topical 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 topical gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide topical gel or from the underlying maternal condition.
  • Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide topical 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 topical 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 topical 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 to 5.0 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide topical 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 6.0 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 Sumary Adapalene gel, 0.3% There are no data on the presence of adapalene topical 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 topical gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide topical gel or from the underlying maternal condition.
  • Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide topical 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 topical gel directly to the nipple and areola to
  • avoid direct infant exposure.
  • 8.4 Pediatric Use Safety and effectiveness of adapalene and benzoyl peroxide topical gel in pediatric patients under the age of 12 have not been established.
  • 8.5 Geriatric Use Clinical studies of adapalene and benzoyl peroxide topical 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 topical 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 topical 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 Alembic Pharmaceuticals, Inc. at 1-866-210-9797 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 topical 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 topical gel and for which the rate with adapalene and benzoyl peroxide topical 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 Topical 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 Topical 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 topical 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 topical 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 topical gel may cause irritation such as erythema, scaling, dryness, stinging or burning [see Warnings and Precautions ( 5.3 )].
  • Lactation Use adapalene and benzoyl peroxide topical 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 topical 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 topical 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 topical gel may bleach hair and colored fabric.
  • Manufactured for: Alembic Pharmaceuticals, Inc.
  • Bedminster, NJ 07921, USA Manufactured by:
  • Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India.
  • Mfg.
  • License No.:
  • G/25/2216 Patient Information Adapalene (a dap' a leen) and Benzoyl Peroxide (BEN-zoe-il per-OX-ide) Topical Gel Important information:
  • Adapalene and benzoyl peroxide topical gel is for use on the skin only (topical).
  • Do not use adapalene and benzoyl peroxide topical gel in or on your mouth, eyes, or vagina.
  • What is adapalene and benzoyl peroxide topical gel? Adapalene and benzoyl peroxide topical gel is a prescription medicine used on the skin (topical) to treat acne vulgaris.
  • It is not known if adapalene and benzoyl peroxide topical gel is safe and effective in
  • children under 12 years of age.
  • Do not use adapalene and benzoyl peroxide topical gel
  • if you have had an allergic reaction to benzoyl peroxide or any of the ingredients in adapalene and benzoyl peroxide topical gel.
  • See the end of this Patient Information leaflet for a complete list of ingredients in adapalene and benzoyl peroxide topical gel.
  • Before using adapalene and benzoyl peroxide topical gel, tell your doctor about all of your medical conditions, including
  • if you:
  • have other skin problems, including cuts, abrasions, sunburn or eczema. are pregnant or plan to become pregnant.
  • It is not known if adapalene and benzoyl peroxide topical gel can harm your unborn baby. are breastfeeding or plan to breastfeed.
  • It is not known if adapalene and benzoyl peroxide topical gel passes into your breast milk and if it can harm your baby.
  • Talk to your doctor about the best way to feed your baby
  • if you use adapalene and benzoyl peroxide topical gel.
  • If you use adapalene and benzoyl peroxide topical gel while breastfeeding, use adapalene and benzoyl peroxide topical gel on
  • the smallest area of the skin and for the shortest time needed.
  • Do not apply adapalene and benzoyl peroxide topical gel directly to the nipple and the areola to minimize contact with your baby.
  • Tell your doctor about all the medicines
  • you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • How should I use adapalene and benzoyl peroxide topical gel? Use adapalene and benzoyl peroxide topical gel exactly as your doctor tells you to use it.
  • Apply adapalene and benzoyl peroxide topical gel 1 time a day.
  • Do not use more adapalene and benzoyl peroxide topical gel than you need to cover the treatment area.
  • Using too much adapalene and benzoyl peroxide topical gel or using it more than 1 time a day may increase your chance of skin irritation.
  • Applying adapalene and benzoyl peroxide topical gel:
  • Wash the area where the gel will be applied with a mild or soapless cleanser and pat dry.
  • Adapalene and benzoyl peroxide topical gel comes in a pump.
  • Depress the pump to dispense a small amount (about the size of a pea) of adapalene and benzoyl peroxide topical gel and spread a thin layer over the treatment area.
  • Use a pea-sized amount for each area of the face (forehead, chin, and each cheek).
  • Wash your hands right away after applying the gel.
  • Adapalene and benzoyl peroxide topical gel may bleach your hair or colored fabrics.
  • Allow adapalene and benzoyl peroxide topical gel to dry completely before dressing to prevent bleaching of your clothes.
  • What should I
  • avoid while using adapalene and benzoyl peroxide topical gel?
  • Avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps.
  • Adapalene and benzoyl peroxide topical gel can make your skin sensitive to sun and the light from tanning beds and sunlamps.
  • Use sunscreen and wear a hat and clothes that cover the areas treated with adapalene and benzoyl peroxide topical gel
  • if you have to be in sunlight.
  • Cold weather and wind may irritate skin treated with adapalene and benzoyl peroxide topical gel.
  • Avoid applying adapalene and benzoyl peroxide topical gel to cuts, abrasions, and sunburned skin.
  • Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes.
  • Avoid the use of "waxing" as a hair removal method on skin treated with adapalene and benzoyl peroxide topical gel.
  • What are the possible side effects of adapalene and benzoyl peroxide topical gel? Adapalene and benzoyl peroxide topical gel may cause serious side effects including:
  • Allergic reactions.
  • Stop using adapalene and benzoyl peroxide topical gel and get medical help right away
  • if you have any of the following symptoms during treatment with adapalene and benzoyl peroxide topical gel:
  • ○ hives, rash or severe itching ○ swelling of your face, eyes, lips, tongue, or throat ○ trouble breathing or throat tightness ○ feeling faint, dizzy, or lightheaded Skin Irritation.
  • Skin irritation is common with adapalene and benzoyl peroxide topical gel and is most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of adapalene and benzoyl peroxide topical gel.
  • Skin reactions at the treatment area include redness, scaling, dryness, stinging, burning, itching and swelling.
  • Tell your doctor if you get any skin reactions.
  • Sensitivity to sunlight.
  • See "What should I
  • avoid while using adapalene and benzoyl peroxide topical gel ?" These are not all of the possible side effects of adapalene and benzoyl peroxide topical gel.
  • Call your doctor for medical advice about side effects.
  • You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store adapalene and benzoyl peroxide topical gel? Store adapalene and benzoyl peroxide topical gel at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep adapalene and benzoyl peroxide topical gel out of light and away from heat.
  • Keep adapalene and benzoyl peroxide topical gel and all medicines out of the reach of children.
  • General information about the safe and effective use of adapalene and benzoyl peroxide topical gel Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
  • Do not use adapalene and benzoyl peroxide topical gel for a condition for which it was not prescribed.
  • Do not give adapalene and benzoyl peroxide topical gel to other people, even if they have the same symptoms
  • you have.
  • It may harm them.
  • You can ask your doctor or pharmacist for information about adapalene and benzoyl peroxide topical gel that is written for health professionals.
  • What are the ingredients in adapalene and benzoyl peroxide topical gel? Active ingredient:
  • adapalene and benzoyl peroxide Inactive ingredients:
  • acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, polaxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate.
  • Manufactured for: Alembic Pharmaceuticals, Inc.
  • Bedminster, NJ 07921, USA Manufactured by:
  • Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India.
  • Mfg.
  • License No.:
  • G/25/2216 For more information, call Alembic Pharmaceuticals, Inc. at 1-866-210-9797.
  • This Patient Information has been approved by the U.S.
  • Food and Drug Administration.
  • Revised: 05/2025

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

Strengths and forms

  • FORMS AND STRENGTHS Each gram of adapalene and benzoyl peroxide topical gel USP contains 3 mg (0.3%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque gel.
  • Adapalene and benzoyl peroxide topical gel USP is available in pump containing 45 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 topical 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 62332-662-45
  • Storage and handling
  • Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° 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 topical gel USP, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%.
  • Adapalene, 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 Benzoyl peroxide 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 topical gel USP contains the following inactive ingredients:
  • acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate.
  • 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 (2)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 2 of 2

Details

Made byAlembic Pharmaceuticals Inc.
Active substanceAdapalene and Benzoyl Peroxide Topical
Used inSkin
Strength3 mg/g + 25 mg/g
FormGel
RouteTopical
Packs1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP
NDC62332-662

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).

Report wrong or outdated information on this page

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.

Adapalene and Benzoyl Peroxide3 mg/g + 25 mg/gPrescription onlyGel Alembic Pharmaceuticals Limited · Adapalene and Benzoyl Peroxide Topical

See every product with Adapalene and Benzoyl Peroxide Topical