ADAPALENE AND BENZOYL PEROXIDE 3 mg/g; 25 mg/g Gel, 45 g
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Peroxides class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 918X1OUF1E
Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
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UNII 1S66E28KXA
Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 1DXE3F3OZX
A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
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UNII 06XEA2VD56
Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.75 | $78.82 / 45 g |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 00480-3154-45 | Teva | 1 bottle | $0.694 | AB | Availability likely | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 45802-0853-45 | Padagis | 45 g | $0.694 | AB | Availability likely | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 62332-0662-45 | Alembic | 1 bottle | $0.694 | AB | Availability likely | — |
| adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 68308-0662-45 | Mayne | 1 bottle | $0.694 | AB | Availability likely | — |
| epiduo forte 3 mg/g; 25 mg/g 00299-5906-00 | Galderma | 2 g | — | AB | FDA listed | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 46708-0662-45 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Adapalene and Benzoyl Peroxide 3 mg/g; 25 mg/g 51672-1384-04 | Sun | 1 bottle | — | AB | FDA listed | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 63629-9322-01 | Bryant | 45 g | — | AB | FDA listed | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 70771-1716-03 | Zydus | 1 bottle | — | AB | FDA listed | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/gthis 72162-1432-02 | Bryant | 45 g | — | AB | FDA listed | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 72578-0119-02 | Viona | 1 bottle | — | AB | FDA listed | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 59651-0604-46 | Aurobindo | 1 bottle | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72162-1432-02 You're viewing this | 45 g in 1 BOTTLE, PUMP (72162-1432-2) | 2024-03-13 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • For topical use only. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/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). • Wash hands after application as Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% may bleach hair or colored fabrics. • Avoid the eyes, lips and mucous membranes. • For topical use only • Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral, ophthalmic, or intravaginal use.
( 2 ) • Apply a thin layer of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each gram of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% is available in pumps containing 45 g. Topical Gel, 0.3%/2.5%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5%. • Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5%. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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, 0.3%/2.5% and may necessitate discontinuation. ( 5.3 )
5.1Hypersensitivity 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, 0.3%/2.5% immediately and initiate appropriate therapy.
5.2Photosensitivity Avoid exposure to sunlight, including sunlamps, during the use of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. 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, 0.3%/2.5%.
5.3Skin Irritation/Contact Dermatitis Erythema, scaling, dryness, and stinging/burning may be experienced with use of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. 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, 0.3%/2.5%, 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, 0.3%/2.5%.
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).
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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, 0.3%/2.5%. 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, 0.3%/2.5% and for which the rate with adapalene and benzoyl peroxide topical gel, 0.3%/2.5% 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 Gel (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 Gel (N=68) Erythema 6% 1% 1% 0% Scaling 6% 0% 1% 0% Dryness 4% 1% 1% 0% Stinging/burning 3% 1% 0% 0%
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of adapalene and benzoyl peroxide topical gel, 0.3%/2.5%. 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available pharmacovigilance data with Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% 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).
8.2Lactation Risk Summary 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, 0.3%/2.5% and any potential adverse effects on the breastfed child from Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% or from the underlying maternal condition.
Clinical Considerations To minimiz…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available pharmacovigilance data with Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% 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).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% in pediatric patients under the age of 12 have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
12.2Pharmacodynamics Pharmacodynamics of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is unknown.
12.3Pharmacokinetics A pharmacokinetic trial was conducted in 26 adult and adolescent subjects (12 to 33 years of age) with severe acne vulgaris who were treated with once-daily applications during a 4-week period with, on average, 2.3 grams/day (range 1.6 - 3.1 grams/day) of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% applied as a thin layer to the face, shoulders, upper chest, and upper back. After a 4-week treatment, 16 subjects (62%) had quantifiable adapalene plasma concentrations above the limit of quantification of 0.1 ng/mL, with a mean C max of 0.16 ± 0.08 ng/mL and a mean AUC 0-24hr of 2.49 ± 1.21 ng.h/mL.
The most exposed subject had adapalene C max and AUC 0-24hr of 0.35 ng/mL and 6.41 ng.h/mL, respectively. Excretion of adapalene appears to be primarily by the biliary route. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.
Drug Interactions No formal drug-drug interaction studies were conducted with Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as a 45 gram pump NDC: 72162-1432-2: 45 g in a BOTTLE, PUMP
16.2Storage and handling Store at controlled room temperature 20° – 25°C (68° – 77°F) with excursions permitted to 15° – 30°C (59° – 86°F) [see USP controlled room temperature]. Keep away from heat. Protect from light. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Adapalene and Benzoyl Peroxide Topical Gel, 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, 0.3%/2.5% 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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, 0.3%/2.5% 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, 0.3%/2.5% 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, 0.3%/2.5% 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, 0.3%/2.5% 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, 0.3%/2.5% 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, 0.3%/2.5% may bleach hair and colored fabric.