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Adapalene 1 mg/g Cream — NDC 63629-8791-01 package photo

Adapalene 1 mg/g Cream

by Bryant Ranch Prepack · 1 TUBE in 1 CARTON (63629-8791-1) / 45 g in 1 TUBE
NDC 63629-8791-01
🏷️ FDA NDC (as labeled) 63629-8791-1 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) 63629-8791-1
Product NDC 63629-8791
11-digit billing NDC 63629879101
NCPDP billing unit GM — per gram (weight)
RxCUI 313852
UNII 1L4806J2QF
Application # ANDA090824
SPL Set ID 5f8189a2-a7ec-441b-993c-fed28b3ae24f
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 2010-06-30
Route TOPICAL
Dosage form CREAM
Substance ADAPALENE
GPI-14 90050003003710
GPI class Adapalene
GCN Seq No 031789
GCN 29301
HICL code 011233
Ingredient (HICL) Adapalene
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L9
Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous
HIC3 code L9B
Therapeutic class — specific (HIC3) Vitamin A Derivatives
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name ADAPALENE 0.1% CREAM
FDB brand name Adapalene
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 63629-8791-1 — 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 → 63629-8791-01. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne
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 holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA090824 (ANDA)
Labeler code63629
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio4,434 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 0.1% CREAM Ingredient Adapalene
📖 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 ↗
📗 Our plain-language guide HelloPharmacist
  • Most people start to see meaningful improvement after 8 to 12 weeks of consistent use. In the early weeks, your acne might actually look a little worse before it gets better — this...
  • How long does it take for adapalene to clear up my acne?
  • Yes, redness, dryness, flaking, and mild stinging are the most common side effects, especially in the first few weeks. They're usually mild to moderate and tend to get better as yo...
  • My skin is really red and dry after starting adapalene — is that normal?
📖 Read our full Adapalene guide →
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 Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 7QWM220FJH
    Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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 $2.81 $126.31 / 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 1 mg/g 70000-0666-01 Cardinal 1 tube $0.467 Availability likely
Adapalene 1 mg/g 46122-0768-36 AMERISOURCE 1 tube $0.467 Availability likely
Adapalene 1 mg/g 00536-1412-20 RUGBY 1 tube $0.467 Availability likely
Adapalene 1 mg/g 51672-2150-01 Sun 1 tube $0.467 Availability likely
Adapalene 1 mg/g 00168-0424-46 E. 1 tube $2.490 AB Availability likely
Adapalene .1 g/100g 45802-0453-84 Padagis 1 tube $2.490 AB Availability likely
Adapalene 1 mg/gthis 63629-8791-01 Bryant 1 tube AB FDA listed
Adapalene 1 mg/g 72162-1048-02 Bryant 1 tube AB FDA listed
Differin 1 mg/g 00299-4910-00 Galderma 1 tube FDA listed
Adapalene 1 mg/g 41250-0288-05 MEIJER, 1 tube FDA listed
Adapalene 1 mg/g 49967-0354-01 LOreal 1 tube FDA listed
Effaclar 1 mg/g 49967-0591-01 LOreal 1 tube FDA listed
Adapalene 1 mg/g 59726-0888-05 P 1 tube FDA listed
Adapalene 1 mg/g 79481-1140-05 Meijer 1 tube FDA listed
PanOxyl 1 mg/g 00316-0143-15 CROWN 1 tube FDA listed
Adapalene 1 mg/g 73581-0215-45 YYBA 1 tube FDA listed
Adapalene 1 mg/g 55910-0880-05 Dolgencorp, 1 tube FDA listed
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment 1 mg/g 69968-0945-02 Kenvue 1 tube FDA listed
Neutrogena Adapalene 0.1% Acne Treatment 1 mg/g 69968-0826-01 Kenvue 1 tube FDA listed
Adapalene 1 mg/g 21130-0754-05 Safeway, 1 tube FDA listed
Adapalene 1 mg/g 00363-1401-05 Walgreens 1 tube FDA listed
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment 1 mg/g 69968-1004-02 Kenvue 1 tube FDA listed
Adapalene 1 mg/g 72657-0158-15 GLENMARK 1 bottle FDA listed
Adapalene 1 mg/g 73581-0019-06 YYBA 1 tube FDA listed
Adapalene 1 mg/g 59726-0114-05 P 1 tube FDA listed
Adapalene 1 mg/g 73581-0214-06 YYBA 1 tube FDA listed
Adapalene 1 mg/g 76162-0114-05 Topco 1 tube FDA listed
Adapalene 1 mg/g 82442-0105-01 Target 1 tube FDA listed
Adapalene 1 mg/g 11822-0062-01 RITE 1 tube FDA listed
Adapalene 1 mg/g 30142-0725-05 The 1 tube FDA listed
Adapalene 1 mg/g 36800-0088-05 TOP 1 tube FDA listed
Adapalene 1 mg/g 69842-0088-05 CVS 1 tube FDA listed
Effaclar 1 mg/g 49967-0592-01 LOreal 1 tube FDA listed
PanOxyl 1 mg/g 00316-0284-15 CROWN 1 tube FDA listed
Adapalene 1 mg/g 00363-4110-05 Walgreens 1 tube FDA listed
Adapalene 1 mg/g 73581-0216-45 YYBA 1 tube FDA listed
Adapalene 1 mg/g 51316-0114-05 CVS 1 tube FDA listed
Adapalene 1 mg/g 00363-0888-05 Walgreens 1 tube FDA listed
Adapalene 1 mg/g 79903-0338-05 Wal-Mart 1 tube 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

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Adapalene — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Adapalene. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$999.6K
Claims incl. refills
2.4K
Beneficiaries
1.8K
Spend / beneficiary
$553.81
Spend / claim
$410.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 — the ingredient across all brands.

Top reported reactions

Dry Skin45,488
Skin Burning Sensation41,990
Acne39,479
Erythema38,668
Skin Irritation26,529
Skin Exfoliation21,435
Rash15,765

Age at onset

Infant1
Child31
Adolescent122
Adult596
Elderly14

Reporter sex

181,513 reports
Male · 22%
Female · 78%
Unknown · 0%

Serious outcomes

Hospitalization377
Disabling41
Life-threatening40
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 5,262 1,284
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
63629-8791-01 You're viewing this 1 TUBE in 1 CARTON (63629-8791-1) / 45 g in 1 TUBE 2010-06-30 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 63629-8791-1, 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: 63629-8791-01, written without dashes as 63629879101. 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 63629-8791-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (8791) 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 14 words

INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.

⏱️ Dosage and Administration 62 words

DOSAGE AND ADMINISTRATION: Adapalene cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene cream.

Contraindications 23 words

CONTRAINDICATIONS: Adapalene cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

🤒 Adverse Reactions 179 words

ADVERSE REACTIONS: In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used adapalene cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with adapalene cream from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritations with Adapalene Cream from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% (28) <1% (1) Scaling 58% (166) 35% (100) 6% (18) <1% (1) Dryness 48% (136) 42% (121) 9% (26) <1% (2) Pruritis (persistent) 74% (211) 21% (61) 4% (12) <1% (1) Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) <1% (2) Other reported local cutaneous adverse events in patients who used adapalene cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%).

Events occurring in less than 1% of patients treated with adapalene cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

🔄 Drug Interactions 101 words

Drug Interactions: As adapalene cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream.

If these preparations have been used, it is advisable not to start therapy with adapalene cream until the effects of such preparations in the skin have subsided.

🤰 Pregnancy 129 words

Pregnancy: Teratogenic effects. Pregnancy Category C. No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day adapalene (up to 20 times the MRHD based on mg/m 2 comparisons).

However, adapalene administered orally at doses of ≥ 25 mg/kg, (100 times the MRHD for rats or 200 times MRHD for rabbits) has been shown to be teratogenic. Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day (24 times the MRHD for rats or 48 times the MRHD for rabbits) exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate and well-controlled studies in pregnant women.

Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 17 words

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established.

🧓 Geriatric Use 55 words

Geriatric Use: Clinical studies of adapalene cream were conducted in patients 12 to 30 years of age with acne vulgaris and therefore did not include subjects 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 71 words

OVERDOSAGE: Adapalene cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of adapalene cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

🧬 Clinical Pharmacology 157 words

CLINICAL PHARMACOLOGY: Mechanism of Action: Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein.

Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Pharmacokinetics: Absorption of adapalene from adapalene cream through human skin is low. In a pharmacokinetic study with six acne patients treated once daily for 5 days with 2 grams of adapalene cream applied to 1000 cm 2 of acne involved skin, there were no quantifiable amounts (limit of quantification = 0.35 ng/mL) of adapalene in the plasma samples from any patient.

Excretion appears to be primarily by the biliary route.

🧬 Mechanism of Action 85 words

Mechanism of Action: Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein.

Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

📦 How Supplied / Storage and Handling 47 words

HOW SUPPLIED: Adapalene Cream, 0.1% is supplied in 45 g tube: NDC 63629-8791-1 Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C). Excursions permitted between 59° and 86° F (15° and 30° C). Protect from freezing. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 87 words

DESCRIPTION: Adapalene cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water.

The molecular formula is C 28 H 28 O 3 and molecular weight is 412.52. Adapalene is represented by the following structural formula:

💬 Information for Patients 189 words

Information for Patients: Patients using adapalene cream should receive the following information and instructions: 1. This medication is to be used only as directed by the physician. 2.

It is for external use only. 3. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.

4. Cleanse area with a mild or soapless cleanser before applying this medication. 5.

Moisturizers may be used if necessary, however, products containing alpha hydroxyl or glycolic acids should be avoided. 6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.

7. This medication should not be applied to cuts, abrasions, eczematous or sunburned skin. 8.

Wax epilation should not be performed on treated skin due to the potential for skin erosions. 9. During the early weeks of therapy, an apparent exacerbation of acne may occur.

This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Overall clinical benefit may be noticed after two weeks of therapy, but at least eight weeks are required to obtain consistent beneficial effects.

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.