Halobetasol Propionate .5 mg/g Cream, 50 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Halobetasol Propionate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
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Methylisothiazolinone is a synthetic chemical preservative that prevents bacterial and fungal growth in liquid medicines and topical products. It helps keep the medication safe and extends shelf life during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.419 | $20.93 / 50 g |
| Medicaid paysCMS SDUD · 12 mo | $0.6401 | $32.01 / 50 g |
| Medicare drug plans payPart D · Q2 2026 | $0.7373 | $36.87 / 50 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Halobetasol Propionate .5 mg/gthis 00713-0640-86 | Cosette | 50 g | $0.419 | AB | Availability likely | — |
| Halobetasol Propionate .5 mg/g 45802-0129-32 | Padagis | 1 tube | $0.419 | AB | Availability likely | — |
| Halobetasol Propionate .5 mg/g 45802-0131-32 | Padagis | 1 tube | $0.440 | AB | Availability likely | +5% |
| Halobetasol Propionate .5 mg/g 70752-0119-02 | QUAGEN | 1 tube | $0.839 | AB | Availability likely | +100% |
| Halobetasol Propionate .5 mg/g 00713-0339-15 | Cosette | 1 tube | $0.839 | AB | Availability likely | +100% |
| Halobetasol Propionate .5 mg/g 72162-2331-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ultravate .5 mg/g 73159-0008-60 | Lacer | 1 bottle | — | — | FDA listed | — |
| Halobetasol Propionate .5 mg/g 72162-2258-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Halobetasol Propionate .5 mg/g 85437-0008-60 | Coral | 1 bottle | — | — | 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 63629-8664-01 | 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 21922-0108-04 | Encube | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00713-0640-15 | 15 g in 1 TUBE (0713-0640-15) | $0.6698 / g | $10.05 | 2007-07-16 | Active |
| 00713-0640-86 You're viewing this | 50 g in 1 TUBE (0713-0640-86) | $0.4185 / g | $20.93 | 2007-07-16 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.4185 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00713-0640-86?
What is the difference between NDC 00713-0640-86 and NDC 00713-0640-15?
What NDC number is used to bill for this package of Halobetasol Propionate .5 mg/g Cream?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Halobetasol Propionate Cream, 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. Use in children 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 ▾
DOSAGE AND ADMINISTRATION Apply a thin layer of Halobetasol Propionate Cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol Propionate Cream is a super-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 Cream should not be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS Halobetasol Propionate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate Cream included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles 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 Cream.
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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
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 Cream. 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 the teratogenic potential of halobetasol propionate in pregnant women. Halobetasol Propionate Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of Halobetasol Propionate Cream 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 axis suppression and Cushing's syndrome when they are treated with topical corti-costeroids. 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 ▾
Geriatric Use Of approximately 400 patients treated with Halobetasol Propionate Cream 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 ▾
OVERDOSAGE Topically applied Halobetasol Propionate Cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
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 Halobetasol Propionate Cream. Studies performed with Halobetasol Propionate Cream indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Halobetasol Propionate Cream, 0.05% is supplied in thefollowing tube sizes: 15 g (NDC 0713-0640-15) 50 g (NDC 0713-0640-86) STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0640CPLNC2 Rev. 08/2022 VC7645
📦 Storage and Handling ▾
STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0640CPLNC2 Rev. 08/2022 VC7645
📋 Description ▾
DESCRIPTION Halobetasol Propionate Cream, 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 Cream contains 0.5 mg/g of halobetasol propionate in a cream base of cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, (and) methylisothiazolinone and water.
Halobetasol Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients using topical corticosteroids should receive the following information and instructions: The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
The medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, other-wise covered or wrapped, so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions.