HomeNDC LookupIngredientsClobetasol Propionate › 50090-8001-00
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Clobetasol Propionate .5 mg/g Ointment

by A-S Medication Solutions · 1 TUBE in 1 CARTON (50090-8001-0) / 30 g in 1 TUBE
NDC 50090-8001-00
🏷️ FDA NDC (as labeled) 50090-8001-0 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 →
⚠️
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) 50090-8001-0
Product NDC 50090-8001
11-digit billing NDC 50090800100
NCPDP billing unit GM — per gram (weight)
RxCUI 861448
UNII 779619577M
Application # ANDA215990
SPL Set ID 8da21ad7-4d2d-4168-82ee-ebf13ce5e923
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 2026-02-01
Route TOPICAL
Dosage form OINTMENT
Substance CLOBETASOL PROPIONATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50090-8001-0 — 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 → 50090-8001-00. 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

LabelerA-S Medication Solutions
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA215990 (ANDA)
Labeler code50090
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio2,774 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:

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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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/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/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/gthis 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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
50090-8001-00 You're viewing this 1 TUBE in 1 CARTON (50090-8001-0) / 30 g in 1 TUBE 2026-06-18 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 50090-8001-0, 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: 50090-8001-00, written without dashes as 50090800100. 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 50090-8001-00, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (8001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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 97 words

INDICATIONS AND USAGE Clobetasol propionate ointment 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/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 USP, to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE). Clobetasol propionate ointment USP, 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. Clobetasol propionate ointment USP, 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 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'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.

🤰 Pregnancy 209 words

Pregnancy: Teratogenic Effects: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse.

Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate ointment.

Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate ointment.

Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 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's 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's 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 18 words

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

🧬 Clinical Pharmacology 179 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 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 they are in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 16 words

HOW SUPPLIED Product: 50090-8001 NDC: 50090-8001-0 30 g in a TUBE / 1 in a CARTON

📋 Description 100 words

DESCRIPTION Clobetasol propionate ointment USP, contain 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 (11β, 16 β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 CIF0 5 and a molecular weight of 467.

It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate ointment USP, clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. 446

💬 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 ↗
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.