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clobetasol propionate .5 mg/g Ointment — NDC 40032-0096-61 package photo

clobetasol propionate .5 mg/g Ointment

by Novel Laboratories, Inc. · 1 TUBE in 1 CARTON (40032-096-61) / 30 g in 1 TUBE
NDC 40032-0096-61
🏷️ FDA NDC (as labeled) 40032-096-61 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Pack sizes3 compare ↓
Also priced by: Part D plans $0.2669/unit — full pricing hub ↓
Also comes in: 15 g 40032-0096-60 60 g 40032-0096-62
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) 40032-096-61
Product NDC 40032-096
11-digit billing NDC 40032009661
RxCUI 861448
UNII 779619577M
UPC 0340032096603
Application # ANDA208841
SPL Set ID c7c03887-f84a-417e-a8f1-5272f530d0bb
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 2016-11-25
Route TOPICAL
Dosage form OINTMENT
Substance CLOBETASOL PROPIONATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 40032-096-61 — 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 → 40032-0096-61. 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

LabelerNovel Laboratories, Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA208841 (ANDA)
Labeler code40032
First marketedNov 2016
Product typeHuman Prescription Drug
Portfolio22 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

📖 What it is MedlinePlus · NLM

Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Clobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 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.

💊 What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 $8.01 / 30 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/gthis 40032-0096-61 Novel 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 42291-0077-15 AvKARE 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 46708-0465-15 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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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 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
40032-0096-60 1 TUBE in 1 CARTON (40032-096-60) / 15 g in 1 TUBE 2016-11-25 Active
40032-0096-61 You're viewing this 1 TUBE in 1 CARTON (40032-096-61) / 30 g in 1 TUBE 2016-11-25 Active
40032-0096-62 1 TUBE in 1 CARTON (40032-096-62) / 60 g in 1 TUBE 2016-11-25 Active

Pack size FAQ

What quantity is in NDC 40032-0096-61?
NDC 40032-0096-61 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of clobetasol propionate .5 mg/g Ointment?
Bill NDC 40032-0096-61 — the 11-digit billing format is 40032009661. 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 40032-096-61, 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: 40032-0096-61, written without dashes as 40032009661. 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 40032-0096-61, the first segment (40032) is the labeler code FDA assigned to Novel Laboratories, Inc.; the middle segment (0096) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (61) 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 Novel Laboratories, Inc.. 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 2 other package presentations of this same product, including 1 tube (40032-0096-60), 1 tube (40032-0096-62). 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?
Novel Laboratories, Inc. 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 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 98 words ▾

INDICATIONS AND USAGE Clobetasol propionate ointment USP is a super-high potency corticosteroid formulation 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/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 133 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/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. Clobetaol 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 23 words ▾

CONTRAINDICATIONS Clobetasol propionate ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

🤒 Adverse Reactions 117 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 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.

🧒 Pediatric Use 148 words ▾

Pediatric Use: Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. Use in pediatric patients under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing syndrome when they are treated with topical corticosteroids.

They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 78 words ▾

Geriatric Use: A limited number of patients at or above 65 years of age have been treated with clobetasol propionate ointment (n = 101) in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of clobetasol propionate ointment in geriatric patients is warranted.

🆘 Overdosage 19 words ▾

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

🧬 Clinical Pharmacology 178 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. 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 dressing 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 it is in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 62 words ▾

HOW SUPPLIED Clobetasol propionate ointment USP, 0.05% is a white to off white ointment and supplied in: 15-g tubes (NDC 40032-096-60) 30-g tubes (NDC 40032-096-61) 60-g tubes (NDC 40032-096-62) 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: Novel Laboratories, Inc. Somerset, NJ 08873 PI0960000102 Rev. 05/2016

📋 Description 105 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. Chemically, clobetasol propionate is (11ß, 16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1, 4-diene-3, 20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 32 CIFO 5 and a molecular weight of 467.

It is a white or almost white crystalline powder insoluble in water. Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. Structure

💬 Information for Patients 87 words ▾

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions to the physician.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 40032-0090-19 · Novel 40032-0118-03 · Novel →
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.