HomeNDC LookupIngredientsHalobetasol Propionate › 45802-0131-35
Halobetasol Propionate .5 mg/g Ointment — NDC 45802-0131-35 package photo

Halobetasol Propionate .5 mg/g Ointment

by Padagis Israel Pharmaceuticals Ltd · 1 TUBE in 1 CARTON (45802-131-35) / 15 g in 1 TUBE
NDC 45802-0131-35
🏷️ FDA NDC (as labeled) 45802-131-35 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.8391 NADAC Per package$12.59 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.01/unit · Part D plans $1.11/unit — full pricing hub ↓
Also comes in: 50 g 45802-0131-32
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) 45802-131-35
Product NDC 45802-131
11-digit billing NDC 45802013135
NCPDP billing unit GM — per gram (weight)
RxCUI 977978
UNII 91A0K1TY3Z
Application # ANDA076872
SPL Set ID c420da92-a3e3-4760-8cad-e50cbacebfeb
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 2009-02-05
Route TOPICAL
Dosage form OINTMENT
Substance HALOBETASOL PROPIONATE
GPI-14 90550073104210
GPI class Halobetasol Propionate
GCN Seq No 015606
GCN 31211
HICL code 006037
Ingredient (HICL) Halobetasol Propionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name HALOBETASOL PROP 0.05% OINTMNT
FDB brand name Halobetasol Propionate
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 45802-131-35 — 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 → 45802-0131-35. 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, potent (group III)
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

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA076872 (ANDA)
Labeler code45802
First marketedFeb 2009
Product typeHuman Prescription Drug
Portfolio175 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 HALOBETASOL PROP 0.05% OINTMNT Ingredient Halobetasol Propionate
📖 What it is MedlinePlus · NLM

Halobetasol topical is used to treat redness, swelling, itching, and discomfort of various skin conditions in adults and children 12 years of age and older, including plaque 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). Halobetasol 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
  • Halobetasol topical is used to treat inflammatory skin conditions — conditions that cause redness, swelling, and itching. The ointment form is used broadly for skin conditions that...
  • You should use halobetasol topical for no longer than two consecutive weeks, and no more than 50 grams total per week. It's a very potent steroid, and using it longer or in larger...
  • Yes — avoid applying halobetasol to your face, groin, or underarms. These areas have thinner skin and absorb much more of the medication, increasing your risk of side effects. Also...
  • Are there places I should not apply this?
📖 Read our full Halobetasol Topical guide →

Supplement & herbal interactions

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

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 U6XF9NP8HM
    Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
  • 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.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

5 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 $0.839 $12.59 / 15 g
Medicaid paysCMS SDUD · 12 mo $1.01 $15.13 / 15 g
Medicare drug plans payPart D · Q2 2026 $1.11 $16.59 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.916 $0.661
▼ Down 38% over the last 24 months.
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
Halobetasol Propionate .5 mg/g 45802-0129-32 Padagis 1 tube $0.419 AB Availability likely save 50%
Halobetasol Propionate .5 mg/g 00713-0640-15 Cosette 15 g $0.670 AB Availability likely save 20%
Halobetasol Propionate .5 mg/g 00713-0339-15 Cosette 1 tube $0.839 AB Availability likely
Halobetasol Propionate .5 mg/gthis 45802-0131-35 Padagis 1 tube $0.839 AB Availability likely
Halobetasol Propionate .5 mg/g 70752-0119-02 QUAGEN 1 tube $0.839 AB Availability likely
Halobetasol Propionate .5 mg/g 63629-8664-01 Bryant 1 tube AB FDA listed
Halobetasol Propionate .5 mg/g 63629-8665-01 Bryant 1 tube AB FDA listed
Halobetasol Propionate .5 mg/g 72162-1396-02 Bryant 1 tube AB FDA listed
Halobetasol Propionate .5 mg/g 72162-2067-02 Bryant 1 tube AB FDA listed
Halobetasol Propionate .5 mg/g 72162-2258-02 Bryant 1 tube AB FDA listed
Ultravate .5 mg/g 73159-0008-60 Lacer 1 bottle FDA listed
Halobetasol Propionate .5 mg/g 85437-0008-60 Coral 1 bottle FDA listed
Halobetasol Propionate .5 mg/g 72162-2331-02 Bryant 1 tube AB FDA listed
Halobetasol Propionate .5 mg/g 21922-0108-04 Encube 1 tube AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Feb 2009
📍
2026
Currently FDA-listed
17 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 45802-0131-35, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.9K
Units reimbursed last 4 qtrs
131.7K
Gross reimbursed last 4 qtrs
$132.8K
Avg / prescription
$33.80
Avg / unit
$1.0085
Latest quarter Q4 2025
806Rx
Medicaid pays / g
$1.0085
gross reimbursed
vs
NADAC / g
$0.8391
acquisition cost
=
Spread
+$0.1694
+20% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
53% FFS 47% MCO
Fee-for-service · 2,098 Rx Managed care · 1,830 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 390 units · 6.6 per 100k residents WI Michigan: 10,560 units · 105 per 100k residents MI New York: 54,345 units · 278 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 1,860 units · 27.1 per 100k residents IN Ohio: no data reported OH Pennsylvania: 405 units · 3.1 per 100k residents PA New Jersey: 6,120 units · 65.9 per 100k residents NJ Massachusetts: 8,570 units · 122 per 100k residents MA California: 5,895 units · 15.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,265 units · 50.0 per 100k residents KY West Virginia: no data reported WV Virginia: 2,670 units · 30.6 per 100k residents VA Maryland: 16,935 units · 274 per 100k residents MD Connecticut: 3,600 units · 99.5 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 5,325 units · 49.1 per 100k residents NC South Carolina: 7,860 units · 146 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 605 units · 89.1 per 100k residents DC Hawaii: 1,590 units · 111 per 100k residents HI Texas: 2,655 units · 8.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.1278
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 278 /100k
2 Maryland 274 /100k
3 South Carolina 146 /100k
4 Massachusetts 122 /100k
5 Hawaii 111 /100k
6 Michigan 105 /100k
7 Connecticut 99.5 /100k
8 D.C. 89.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube45802-0131-32 7,990 Rx · $283,021
1 tube this page45802-0131-35 3,928 Rx · $132,766
Drug total (last 4 qtrs): 11,918 Rx · 551,910 units · $415,787 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Halobetasol Propionate — the program that covers self-administered drugs. 4 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 Halobetasol 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
$2.1M
Claims incl. refills
39.2K
Beneficiaries
28.4K
Spend / beneficiary
$73.82
Spend / claim
$53.58
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 Halobetasol Propionate — the ingredient across all brands.

Top reported reactions

Psoriasis233
Pruritus134
Rash102
Pain84
Fatigue81
Arthralgia70
Dermatitis Atopic68

Age at onset

Child9
Adolescent10
Adult361
Elderly104

Reporter sex

1,525 reports
Male · 41%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization189
Death29
Life-threatening14
Disabling11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 276 62
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 Per unit Per pack Marketing startStatus
45802-0131-32 1 TUBE in 1 CARTON (45802-131-32) / 50 g in 1 TUBE $0.4403 / g $22.02 2009-02-05 Active
45802-0131-35 You're viewing this 1 TUBE in 1 CARTON (45802-131-35) / 15 g in 1 TUBE $0.8391 / g $12.59 2010-01-14 Active

Per g, this pack runs about 91% above the cheapest pack (NDC 45802-0131-32, $0.4403 vs $0.8391 NADAC).

This pack accounts for about 33% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0131-35?
NDC 45802-0131-35 is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Halobetasol Propionate .5 mg/g Ointment?
Bill NDC 45802-0131-35 — the 11-digit billing format is 45802013135. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 55 words

INDICATIONS AND USAGE Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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.

⏱️ Dosage and Administration 96 words

DOSAGE AND ADMINISTRATION Apply a thin layer of halobetasol propionate ointment, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol propionate ointment, 0.05% is a high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved.

If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Halobetasol propionate ointment, 0.05% should not be used with occlusive dressings.

Contraindications 23 words

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

🤒 Adverse Reactions 119 words

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate ointment, 0.05% included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as halobetasol propionate ointment, 0.05%.

These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 155 words

Pregnancy Teratogenic effects: Pregnancy Category C: 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 in laboratory animals. Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits.

These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of halobetasol propionate ointment, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats. Cleft palate was observed in both rats and rabbits.

Omphalocele was seen in rats, but not in rabbits. There are no adequate and well-controlled studies of teratogenic potential of halobetasol propionate in pregnant women. Halobetasol propionate ointment, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 146 words

Pediatric Use Safety and effectiveness of halobetasol propionate ointment, 0.05% in pediatric patients have not been established and use in pediatric patients under 12 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 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 71 words

Geriatric Use Of approximately 400 patients treated with halobetasol propionate ointment, 0.05% in clinical studies, 25% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients; and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 20 words

OVERDOSAGE Topically applied halobetasol propionate ointment, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 210 words

CLINICAL PHARMACOLOGY Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, 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 have 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.

Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of the ointment. Studies performed with halobetasol propionate ointment, 0.05% indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 31 words

HOW SUPPLIED Halobetasol propionate ointment, 0.05% is supplied in the following tube sizes: 15 g (NDC 45802-131-35) and 50 g (NDC 45802-131-32) STORAGE Store between 15°C and 30°C (59°F and 86°F).

📦 Storage and Handling 9 words

STORAGE Store between 15°C and 30°C (59°F and 86°F).

📋 Description 105 words

DESCRIPTION Halobetasol propionate ointment, 0.05% contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent. Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C 25 H 31 ClF 2 O 5 .

It has the following structural formula: Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water. Each gram of halobetasol propionate ointment, 0.05% contains 0.5 mg of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, stearyl citrate, petrolatum, propylene glycol and sorbitan sesquioleate. structural formula

💬 Information for Patients 124 words

Information for Patients Patients using topical corticosteroids should receive the following information and instructions: 1. The medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. The medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, or otherwise covered or wrapped, so as to be occlusive unless directed by the physician. 4.

Patients should report to their physician any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressing.

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.