Drugplain

Halobetasol Propionate .5 mg/g

Halobetasol Propionate · OINTMENT · Bryant Ranch Prepack

No Recall History
Plain English

Halobetasol Propionate is a ointment containing halobetasol propionate at .5 mg/g, taken topical. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Halobetasol Propionate
Generic Name
Halobetasol Propionate
NDC Code (Product)
72162-2258
Manufacturer
Bryant Ranch Prepack
Strength
.5 mg/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
ANDA077109
Marketing Start
06/14/2005

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. 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 & Administration

DOSAGE AND ADMINISTRATION Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol Propionate Ointment 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 Ointment should not be used with occlusive dressings.

Contraindications

CONTRAINDICATIONS Halobetasol Propionate Ointment 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 Ointment 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. 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 .

Frequently Asked Questions

What is Halobetasol Propionate used for?

Halobetasol Propionate contains Halobetasol Propionate. It is a ointment taken topical. Consult your doctor for specific uses.

Is Halobetasol Propionate a controlled substance?

Halobetasol Propionate is not classified as a controlled substance by the DEA.

What is the generic name for Halobetasol Propionate?

The generic name for Halobetasol Propionate is Halobetasol Propionate. There are 3 other brand versions of Halobetasol Propionate.

What is the NDC code for Halobetasol Propionate .5 mg/g?

The NDC (National Drug Code) for Halobetasol Propionate .5 mg/g is 72162-2258, listed by Bryant Ranch Prepack.

Product NDC

72162-2258

Package NDC

72162-2258-2

Other Halobetasol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)