Drug Catalog - Product Detail
HALOBETASOL PROPIONATE CREAM CRM 0.0005 15GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0129-35 | PADAGIS | 15 | 0.05% | CREAM |
PACKAGE FILES
Generic Name
HALOBETASOL PROPIONATE
Substance Name
HALOBETASOL PROPIONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA077123
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 CIF 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, 0.05% contains 0.5 mg of halobetasol propionate in a cream base of cetyl alcohol, diazolidinyl urea, glycerin, isopropyl isostearate, isopropyl palmitate, methylchloroisothiazolinone, (and) methylisothiazolinone, steareth-21 and water. structure
How Supplied
HOW SUPPLIED Halobetasol propionate cream, 0.05% is supplied in the following tube sizes: 15 g (NDC 45802- 129 -35) and 50 g (NDC 45802- 129 -32) STORAGE Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature).
Indications & 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 corticosteroid, 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, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol propionate cream, 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 cream, 0.05% should not be used with occlusive dressings.