adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g Gel — NDC 63629-8607-01 package photo

adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g Gel

by Bryant Ranch Prepack · 1 BOTTLE, PUMP in 1 CARTON (63629-8607-1) / 45 g in 1 BOTTLE, PUMP
NDC 63629-8607-01
🏷️ FDA NDC (as labeled) 63629-8607-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 63629-8607-1
Product NDC 63629-8607
11-digit billing NDC 63629860701
NCPDP billing unit GM — per gram (weight)
RxCUI 829539
UNII 1L4806J2QF, W9WZN9A0GM
Application # ANDA205033
SPL Set ID c2b4c7a4-05e5-4e94-9f09-7f8f68f99eab
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-24
Route TOPICAL
Dosage form GEL
Substance ADAPALENE; BENZOYL PEROXIDE
GCN Seq No 068880
GCN 31775
HICL code 036015
Ingredient (HICL) Adapalene/Benzoyl Peroxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name ADAPALENE-BNZYL PEROX 0.1-2.5%
FDB brand name Adapalene-Benzoyl Peroxide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63629-8607-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 63629-8607-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Peroxides class.

Drug family (ATC) Peroxides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA205033 (ANDA)
Labeler code63629
First marketedJan 2018
Product typeHuman Prescription Drug
Portfolio4,433 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ADAPALENE-BNZYL PEROX 0.1-2.5% Ingredient Adapalene/Benzoyl Peroxide
📖 What it is MedlinePlus · NLM

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 ↗
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer gPer 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 $1.13 $50.85 / 45 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g; 25 mg/g 21922-0052-50 Encube 1 bottle $0.329 AB Availability likely
adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 45802-0846-01 Padagis 45 g $0.329 AB Availability likely
ADAPALENE and BENZOYL PEROXIDE 1 mg/g; 25 mg/g 51672-1364-03 Sun 1 bottle $0.329 AB Availability likely
adapalene and benzoyl peroxide 1 mg/g; 25 mg/g 68462-0301-47 Glenmark 1 bottle $0.329 AB Availability likely
Differin Epiduo 1 mg/g; 25 mg/g 00299-4908-00 Galderma 2 g FDA listed
adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100gthis 63629-8607-01 Bryant 1 bottle AB FDA listed
adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 72162-1430-02 Bryant 45 g AB FDA listed
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g; 25 mg/g 72162-2296-02 Bryant 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Adapalene and Benzoyl Peroxide — the ingredient across all brands.

Top reported reactions

Skin Burning Sensation80
Erythema79
Dry Skin64
Acne45
Skin Irritation45
Skin Exfoliation40
Rash35

Age at onset

Adolescent13
Adult21

Reporter sex

418 reports
Male · 28%
Female · 69%
Unknown · 3%

Serious outcomes

Hospitalization19
Life-threatening2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 75 9
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63629-8607-01 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (63629-8607-1) / 45 g in 1 BOTTLE, PUMP 2018-01-24 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63629-8607-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63629-8607-01, written without dashes as 63629860701. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63629-8607-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (8607) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 61 words

1 INDICATIONS AND USAGE Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

⏱️ Dosage and Administration 126 words

2 DOSAGE AND ADMINISTRATION For topical use only; Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Adapalene and Benzoyl Peroxide Gel, 0.1%/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).

Avoid the eyes, lips and mucous membranes. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Adapalene and Benzoyl Peroxide Gel, 0.1%/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). Avoid the eyes, lips and mucous membranes.

💊 Dosage Forms and Strengths 56 words

3 DOSAGE FORMS AND STRENGTHS Each gram of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel. Each gram of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide.

Contraindications 4 words

4 CONTRAINDICATIONS None None.

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. (5.1) Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and may necessitate discontinuation. (5.2)

5.1Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during the use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel, (e.g., hat) are recommended when exposure cannot be avoided.

Weather extremes, such as wind or cold, may be irritating to patients under treatment with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

5.2Local Cutaneous Reactions Erythema, scaling, dryness, and stinging/burning may be experienced with use of Adapalene and Benzoyl Peroxide Gel, 0.1%/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 Gel, 0.1%/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 Gel, 0.1%/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 ~2 min read

6 ADVERSE REACTIONS Most commonly reported adverse events (≥1%) in patients treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel, 0.1%/2.5%. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months.

Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with adapalene and benzoyl peroxide gel, 0.1%/2.5% and those reported in subjects treated with the vehicle gel are presented in Table 1: Table 1 Drug Related Adverse Events Reported in Clinical Trials by At Least 1% of Patients Treated For 12 Weeks System Organ Class/Preferred Term Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% N=564 Vehicle gel N=489 Subjects with AE (s) 14% 4% Dry Skin 7% 2% Contact dermatitis 3% <1% Application site burning 2% <1% Application site irritation 1% <1% Skin irritation 1% 0% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging.

Table 2 Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N=553) Treatment Emergent Signs and Symptoms Maximum Severity During Treatment End of Treatment Severity (12 Weeks) Mild Moderate Severe Mild Moderate Severe Erythema 27% 13% 1% 8% 2% 1% Scaling 35% 11% 1% 9% 1% <1% Dryness 41% 13% 1% 10% 2% <1% Stinging/burning 41% 15% 3% 7% 2% 1% Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.

During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with adapalene and benzoyl peroxide gel, 0.1%/2.5% or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of adapalene and benzoyl peroxide gel, 0.1%/2.5% in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of adapalene and benzoyl peroxide gel, 0.1%/2.5%: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

🔄 Drug Interactions 44 words

7 DRUG INTERACTIONS Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits.

Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m 2 ) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

8.3Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Because many drugs are excreted in human milk, caution should be exercised when Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in pediatric patients under the age of 9 have not been established.

8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel, 0.1%/2.5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 195 words

8.1Pregnancy Pregnancy Category C There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits.

Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m 2 ) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

🧒 Pediatric Use 25 words

8.4Pediatric Use Safety and effectiveness of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in pediatric patients under the age of 9 have not been established.

🧓 Geriatric Use 32 words

8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel, 0.1%/2.5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology 212 words

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 Gel, 0.1%/2.5% is unknown.

12.3Pharmacokinetics A pharmacokinetic study was conducted in 10 adult subjects with acne vulgaris who were treated once daily for 30 days with 2 grams/day of adapalene and benzoyl peroxide gel, 0.1%/2.5% applied to 1000 cm 2 of acne involved skin, (face, chest, and upper back). Two subjects (20%) had quantifiable adapalene plasma concentrations above the limit of quantification (LOQ = 0.1ng/mL). The highest adapalene C max and AUC 0-24h was 0.21 ng/mL and 1.99 ng•h/mL, respectively.

Excretion of adapalene appears to be primarily by the biliary route. Pharmacokinetics of adapalene and benzoyl peroxide gel, 0.1%/2.5% in pediatric subjects have not been evaluated. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.

🧬 Mechanism of Action 75 words

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 65 words

16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram pump NDC 63629-8607-1 Storage and handling -Store at 25°C; excursions permitted to 15° – 30°C (59° – 86°F). -Protect from light. -Keep out of reach of children. -Keep away from heat. -Keep tube tightly closed.

📋 Description 127 words

11 DESCRIPTION Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% 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: 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: Adapalene and Benzoyl Peroxide Gel, 0.1%/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. chemical structure adapalene.jpg chemical structure benzoyl peroxide.jpg

💬 Information for Patients 134 words

17 PATIENT COUNSELING INFORMATION [ See FDA Approved Patient Labeling (Patient Information) ] Information for Patients Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply Adapalene and Benzoyl Peroxide Gel, 0.1%/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.

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may cause irritation such as erythema, scaling, dryness, stinging or burning. Advise patients to minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided.

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may bleach hair and colored fabric.

💬 Patient Medication Information ~3 min read

Patient Information Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% Important: For use on the skin only (topical). Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in or on your mouth, eyes, or vagina. Read this Patient Information leaflet about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% before you start using it and each time you get a refill.

There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, talk with your doctor or pharmacist.

What is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is safe and effective in children younger than 9 years old. What should I tell my doctor before using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? Before you use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, tell your doctor if you: have other skin problems, including cuts or sunburn have any other medical conditions are pregnant or planning to become pregnant.

It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 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 Gel, 0.1%/2.5%. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use any other medicine for acne.

Using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? Use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% exactly as your doctor tells you to use it. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is for skin use only.

Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in or on your mouth, eyes, or vagina. Apply Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 time a day. Do not use more Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% than you need to cover the treatment area.

Using too much Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% or using it more than 1 time a day may increase your chance of skin irritation. Applying Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%: Wash the area where the gel will be applied with a mild cleanser and pat dry. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% comes in a tube and a pump.

If you have been prescribed the: Tube: Squeeze a small amount (about the size of a pea) of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% onto your fingertips and spread a thin layer over the affected area. Pump: Depress the pump to dispense a small amount (about the size of a pea) of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and spread a thin layer over the affected area. What should I avoid while using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%?

You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% if you have to be in sunlight.

You should avoid weather extremes such as w…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.