Halobetasol Propionate

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

ADV ERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for halobelasol 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 Encube Ethicals Pvt. Ltd. at 1-833-285-4151, contact the FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

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 contains 0.5 mg/g of halobetasol propionate in a base of aluminum stearate, white beeswax, pentaerythritol cocoate, propylene glycol, sorbitan sesquioleate, monostearyl citrate, and white petrolatum. chemicalstructure

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

HOW SUPPLIED SECTION Halobetasol propionate ointment, 0.05% is supplied in the following tube size: 15 g (NDC 21922-108-04) 50 g (NDC21922-108-14) STORAGE Store halobetasol propionate ointment between 15°C to 30°C (59°F to 86°F). Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713 USA Revised: 09/2025