Adapalene and Benzoyl Peroxide 3 mg/g; 25 mg/g Gel — NDC 51672-1384-9 (Billing 51672-1384-09)
This is a package of Adapalene and Benzoyl Peroxide 3 mg/g; 25 mg/g Gel from Sun Pharmaceutical Industries, Inc., marketed since Oct 2018 and currently FDA-listed; retail pharmacies pay about $0.6260 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 51672-1384-9 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 51672 labeler · 1384 product · 9 package
- Package marketed since
- Oct 17, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0351672138493
- Medicaid fills, this package
- 216 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 074495
- GCN: 39163
- GPI-14 (Medi-Span): 90059902034030
- HICL (First Databank): 036015
- AHFS class code: 84:92.00.00
- RxCUI (RxNorm): 1663745
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Peroxides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.626 | $28.17 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.9458 | $42.56 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $1.75 | $78.82 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 51672-1384-04 51672-1384-4 | 1 BOTTLE, PUMP in 1 CARTON / 60 g in 1 BOTTLE, PUMP | — | — | 2021-03-11 | — | Active |
| 51672-1384-09 You're viewing this Main listing | 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP | $0.6260 / g | $28.17 | 2018-10-17 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Adapalene and Benzoyl Peroxide 3 mg/g; 25 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
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 | $0.626 | AB | Availability likely | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 45802-0853-45 | Padagis | 45 g | $0.626 | AB | Availability likely | — |
| Adapalene and Benzoyl Peroxide 3 mg/g; 25 mg/gthis 51672-1384-09 | Sun | 1 bottle | $0.626 | AB | Availability likely | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 62332-0662-45 | Alembic | 1 bottle | $0.626 | AB | Availability likely | — |
| adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 68308-0662-45 | Mayne | 1 bottle | $0.626 | 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 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/g 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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 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 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 5F4963KLHS
A synthetic polymer created from acrylamide and sodium acryloyldimethyltaurate that thickens and stabilizes liquid or semi-solid formulations. It helps maintain consistent texture and prevents separation of ingredients in creams, gels, and lotions.
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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.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 51672
- Clobetasol Propionate .05 g/mL Spray NDC 51672-1371-4
- Tazarotene 1 mg/g Cream NDC 51672-1373-2
- Tazarotene 1 mg/g Cream NDC 51672-1374-2
- Naftifine Hydrochloride 20 mg/g Gel NDC 51672-1376-3
- Adapalene 3 mg/g Gel NDC 51672-1377-6
- Clindamycin Phosphate and Benzoyl Peroxide Clindamycin and Benzoyl Peroxide Gel Kit NDC 51672-1381-2
- Ibuprofen 100 mg/5mL Suspension NDC 51672-1385-8
- Fluocinonide .5 mg/g Cream NDC 51672-1386-1
- Dapsone 50 mg/g Gel NDC 51672-1387-2
- Dapsone 75 mg/g Gel NDC 51672-1388-2
- Azelaic Acid .15 g/g Gel NDC 51672-1389-3
- Betamethasone dipropionate .5 mg/g Spray NDC 51672-1390-4
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each gram of adapalene and benzoyl peroxide topical gel contains 3 mg (0.3%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to pale yellow, opaque gel. Adapalene and benzoyl peroxide topical gel is available in pumps containing 45 g or 60 g. Topical Gel, 0.3%/2.5%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 )
⚠️ 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 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 immediately and initiate appropriate therapy.
5.2Photosensitivity 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.
5.3Skin Irritation/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).
🤒 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 Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 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.
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%
6.2Postmarketing 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 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 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 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 vi… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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 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 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 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 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 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 to 3.1 grams/day) of adapalene and benzoyl peroxide topical gel 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.
🧬 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 pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram pump NDC 51672-1384-9 60 gram pump NDC 51672-1384-4
16.2Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep away from heat. Protect from light. Keep out of reach of children.
📦 Storage and Handling ▾
16.2Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep away from heat. Protect from light. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is a white to 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 contains the following inactive ingredients: docusate sodium, edetate disodium, glycerin, poloxamer 124, polyacrylamide & C13-14 isoparaffin & laureth 7 (sepigel 305), propylene glycol and purified water.
Chemical Structure Chemical Structure
💬 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 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.
🧬 Pharmacokinetics ▾
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 to 3.1 grams/day) of adapalene and benzoyl peroxide topical gel 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.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Pharmacodynamics of adapalene and benzoyl peroxide topical gel is unknown.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% applied once daily for 12 weeks for the treatment of acne vulgaris were assessed in a multicenter, randomized, double-blind, vehicle-controlled trial, comparing adapalene and benzoyl peroxide topical gel, 0.3%/2.5% to vehicle gel in subjects with acne vulgaris. The trial also evaluated adapalene and benzoyl peroxide gel, 0.1%/2.5%, a lower strength product than adapalene and benzoyl peroxide topical gel, 0.3%/2.5%. In this trial, 217 subjects were treated with adapalene and benzoyl peroxide topical gel, 0.3%/2.5%, 217 subjects with adapalene and benzoyl peroxide gel, 0.1%/2.5% and 69 subjects with the vehicle gel.
Treatment response was defined as the percent of subjects who were rated "clear" or "almost clear" at Week 12 with at least a two-grade improvement based on the Investigator's Global Assessment (IGA), and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. An IGA score of "Clear" corresponded to clear skin with no inflammatory or non-inflammatory lesions. An IGA score of "almost clear" corresponded to a few scattered comedones and a few small papules.
At baseline, 50% of subjects were graded as "moderate" (IGA Grade 3) and 50% were graded as "severe" (IGA Grade 4) on the IGA scale. Subjects had an average of 98 (range 51 to 226) total lesions of which the mean number of inflammatory lesions was 38 (range: 20 to 99) and the mean number of non-inflammatory lesions was 60 (range 30 to 149). Subjects ranged in age from 12 to 57 years, with 273 (54%) of subjects 12 to 17 years of age.
Approximately equal number of males (48%) and females (52%) were enrolled. The IGA success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12 weeks of treatment are presented in the following table. Table 3.
Clinical Efficacy of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% at Week 12 in Subjects with Acne Vulgaris Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) This trial was not designed or powered to compare the efficacy of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% to the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5%, nor to compare the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5% to the vehicle control.
Vehicle (N=69) IGA: two-grade improvement and "clear" or "almost clear" 33.7% 27.3% 11% Inflammatory lesions: mean absolute (percent) reduction 27.8 (68.7%) 26.5 (69.3%) 13.2 (39.2%) Non-inflammatory lesions: mean absolute (percent) reduction 40.5 (68.3%) 40 (68%) 19.7 (37.4%) In subjects graded as "severe" (IGA Grade 4), efficacy was observed in the adapalene and benzoyl peroxide topical gel, 0.3%/2.5% group.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide topical gel. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD of adapalene and benzoyl peroxide topical gel based on a mg/m 2 comparison.
In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15 to 25% benzoyl peroxide carbopol gel (6 to 10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide topical gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg/kg benzoyl peroxide (27 to 40 times the MRHD based on a mg/m 2 comparison).
Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 year study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. Benzoyl peroxide is a tumor promoter in several animal species. The significance of this finding in humans is unknown.
Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). Benzoyl peroxide caused DNA strand breaks and DNA-protein cross-links in mammalian cells, increased sister chromatid exchanges in Chinese hamster ovary cells, and was mutagenic in a few, but not all, in vitro bacterial mutagenicity assays (Ames tests) conducted. In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
No fertility studies were conducted with benzoyl peroxide.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide topical gel. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD of adapalene and benzoyl peroxide topical gel based on a mg/m 2 comparison.
In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15 to 25% benzoyl peroxide carbopol gel (6 to 10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide topical gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg/kg benzoyl peroxide (27 to 40 times the MRHD based on a mg/m 2 comparison).
Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 year study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. Benzoyl peroxide is a tumor promoter in several animal species. The significance of this finding in humans is unknown.
Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). Benzoyl peroxide caused DNA strand breaks and DNA-protein cross-links in mammalian cells, increased sister chromatid exchanges in Chinese hamster ovary cells, and was mutagenic in a few, but not all, in vitro bacterial mutagenicity assays (Ames tests) conducted. In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
No fertility studies were conducted with benzoyl peroxide.
📄 Patient Package Insert ▾
Patient Information Adapalene (a dap' a leen) and Benzoyl Peroxide (BEN-zoe-il per-OX-ide) Topical Gel This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: December 2022 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 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,… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 45 g Bottle Carton NDC 51672-1384-9 45 g Adapalene and Benzoyl Peroxide Topical Gel 0.3% / 2.5% PUMP FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx only Keep this and all medications out of the reach of children. TARO carton label carton label