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Clobetasol Propionate .5 mg/g Ointment — NDC 46708-0465-45 package photo

Clobetasol Propionate .5 mg/g Ointment

by Alembic Pharmaceuticals Limited · 1 TUBE in 1 CARTON (46708-465-45) / 45 g in 1 TUBE
NDC 46708-0465-45
🏷️ FDA NDC (as labeled) 46708-465-45 billing pads the product segment with a zero
This package
Contains45 g in 1 tube Pack sizes4 compare ↓
Also priced by: Part D plans $0.2669/unit — full pricing hub ↓
Also comes in: 15 g 46708-0465-15 30 g 46708-0465-30 60 g 46708-0465-60
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 3, 2026 — Failed content uniformity specifications. (Lupin Pharmaceuticals Inc.) · FDA recall D-0789-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 46708-465-45
Product NDC 46708-465
11-digit billing NDC 46708046545
RxCUI 861448
UNII 779619577M
UPC 0346708465155
Application # ANDA211800
SPL Set ID 1a4331e1-5c79-44c3-a691-4b808a3bde97
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-12
Route TOPICAL
Dosage form OINTMENT
Substance CLOBETASOL PROPIONATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 46708-465-45 — a 5-3-2 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 product segment → 46708-0465-45. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, very potent (group IV), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA211800 (ANDA)
Labeler code46708
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio502 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

📗 Our plain-language guide HelloPharmacist
  • Clobetasol is a very strong prescription steroid cream (or foam, spray, shampoo, solution, or eye drop) used to calm inflamed, itchy skin. Depending on the specific product, it tre...
  • That's a really important question. Most clobetasol skin products should be used for no more than 2 consecutive weeks. Some formulations can be extended to 4 weeks for certain case...
  • How long can I use this? I've heard you can't use steroids for too long.
  • Do not apply clobetasol to your face, underarms, or groin unless your doctor has specifically told you to — those areas absorb much more of the medication. Also avoid any skin that...
📖 Read our full Clobetasol guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Clobetasol Propionate (3 interactions) — ranked by severity →
8
Nutrient depletion considerations

Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clobetasol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.

3 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 DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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 $0.2669 $12.01 / 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
Clobetasol Propionate .5 mg/g 00713-0656-15 Cosette 1 tube $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 21922-0017-04 Encube 1 tube $0.129 AB Availability likely —
Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 Macleods 1 tube $0.129 AB Availability likely —
clobetasol propionate .5 mg/g 43386-0096-60 Lupin 1 tube $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 51672-1259-01 Sun 1 tube $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 59651-0732-14 Aurobindo 1 tube $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 62332-0465-15 Alembic 1 tube $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 70700-0106-15 Xiromed, 15 g $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 72603-0855-01 NorthStar 1 tube $0.129 AB Availability likely —
Clobetasol Propionate .5 mg/g 69238-1532-03 Amneal 1 tube $0.168 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 51672-1258-01 Sun 1 tube $0.188 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 70700-0109-15 Xiromed, 1 tube $0.188 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 62332-0547-15 Alembic 1 tube $0.188 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 13668-0569-01 Torrent 15 g $0.188 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 00168-0163-15 E. 15 g $0.188 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 68180-0956-01 Lupin 1 tube $0.188 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 68462-0529-17 Glenmark 1 tube $0.224 — FDA listed —
Clobetasol Propionate .5 mg/g 00168-0162-15 E. 15 g $0.295 AB FDA listed —
Clobetasol Propionate .5 mg/g 68462-0530-17 Glenmark 1 tube $0.329 — FDA listed —
Clobetasol Propionate .5 mg/g 70710-1401-01 Zydus 1 tube $0.329 AB FDA listed —
Clobetasol Propionate .5 mg/g 16714-0782-01 Northstar 1 tube $0.329 — Discontinued —
Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 E. 1 tube $0.590 AB2 Availability likely —
Clobetasol Propionate .5 mg/g 51672-1297-01 Sun 1 tube $0.597 AB2 Availability likely —
Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 The 1 tube $0.597 AB2 Availability likely —
Clobetasol Propionate .5 mg/g 00168-0293-15 E. 15 g $0.666 AB FDA listed —
Clobetasol Propionate .5 mg/g 45802-0925-14 Padagis 1 tube $0.710 AB Availability likely —
Clobetasol Propionate .5 mg/g 51672-1294-01 Sun 1 tube $0.710 AB Availability likely —
clobetasol propionate .5 mg/g 40032-0096-60 Novel 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 42291-0077-15 AvKARE 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/gthis 46708-0465-45 Alembic 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-5488-00 A-S 1 tube — — FDA listed —
Clobetasol Propionate .5 mg/g 50090-6402-00 A-S 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-6731-00 A-S 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-8001-00 A-S 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2455-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2456-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2457-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2458-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 68071-3922-05 NuCare 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 68788-7963-01 Preferred 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 70771-1209-01 Zydus 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2837-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2851-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2859-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2860-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 72162-1273-02 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-0549-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 50090-5079-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 50090-6717-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-8637-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-8638-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2331-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2332-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 46708-0547-15 Alembic 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 82804-0083-30 Proficient 30 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 72162-1438-02 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 72162-1961-02 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 Bryant 1 tube — AB2 FDA listed —
Clobetasol Propionate .5 mg/g 72189-0262-30 DIRECT 30 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2329-01 Bryant 60 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2330-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-8639-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 42291-0076-15 AvKARE 1 tube — AB1 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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 Clobetasol Propionate — the program that covers self-administered drugs. 22 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 Clobetasol Propionate. 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
$28.79M
Claims incl. refills
813.5K
Beneficiaries
629K
Spend / beneficiary
$45.78
Spend / claim
$35.39
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 Clobetasol Propionate — the ingredient across all brands.

Top reported reactions

Pruritus925
Rash667
Psoriasis550
Fatigue512
Headache493
Diarrhoea439
Nausea439

Age at onset

Neonate3
Infant4
Child79
Adolescent86
Adult1,895
Elderly1,258

Reporter sex

10,471 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization2,013
Life-threatening245
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,338 630
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
46708-0465-15 1 TUBE in 1 CARTON (46708-465-15) / 15 g in 1 TUBE 2025-02-12 Active
46708-0465-30 1 TUBE in 1 CARTON (46708-465-30) / 30 g in 1 TUBE 2025-02-12 Active
46708-0465-45 You're viewing this 1 TUBE in 1 CARTON (46708-465-45) / 45 g in 1 TUBE 2025-02-12 Active
46708-0465-60 1 TUBE in 1 CARTON (46708-465-60) / 60 g in 1 TUBE 2025-12-02 Active

Pack size FAQ

What quantity is in NDC 46708-0465-45?
NDC 46708-0465-45 is listed by the FDA — 1 tube in 1 carton / 45 g in 1 tube.
What NDC number is used to bill for this package of Clobetasol Propionate .5 mg/g Ointment?
Bill NDC 46708-0465-45 — the 11-digit billing format is 46708046545. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 46708-465-45, 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: 46708-0465-45, written without dashes as 46708046545. 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 46708-0465-45, the first segment (46708) is the labeler code FDA assigned to Alembic Pharmaceuticals Limited; the middle segment (0465) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) 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 Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (46708-0465-15), 1 tube (46708-0465-30), 1 tube (46708-0465-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited 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 ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 101 words ▾

INDICATIONS AND USAGE Clobetasol Propionate Ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

⏱️ Dosage and Administration 134 words ▾

DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE ). Clobetasol propionate ointment is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate ointment should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

🤒 Adverse Reactions 128 words ▾

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 19 words ▾

OVERDOSAGE Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 180 words ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.

Occlusive dressings with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with clobetasol propionate ointment indicate that this is in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 72 words ▾

HOW SUPPLIED Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes as follows: Strength NDC Number 15 g (NDC 46708-465-15) 30 g (NDC 46708-465-30) 45 g (NDC 46708-465-45) 60 g (NDC 46708-465-60) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured by: Alembic Pharmaceuticals limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg.

License No.: G/25/2216 Revised: 02/2025

📋 Description 86 words ▾

DESCRIPTION Clobetasol Propionate Ointment USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water.

Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: structure Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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