FDA label

What is halobetasol propionate used for?

The FDA-approved uses of halobetasol propionate, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “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. ...”

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Halobetasol Propionate, ointment

Indications and Usage, quoted from the label by Encube Ethicals, Inc. (ANDA209978). Cross-references to other label sections are left out.

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.

Source: DailyMed label, set id d4f03a79-3d5e-4a39-8ab0-8ebd3d804e39, version 1, effective June 29, 2026. NDC 21922-108, one of 9 listings for this product.

Halobetasol Propionate, cream

Indications and Usage, quoted from the label by Cosette Pharmaceuticals, Inc. (ANDA078162). Cross-references to other label sections are left out.

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.

Source: DailyMed label, set id 1f57aaae-8d5f-bfdf-08d6-495b84221311, version 8, effective November 23, 2023. NDC 0713-0640, one of 3 listings for this product.

Halobetasol Propionate, aerosol, foam

Indications and Usage, quoted from the label by Mayne Pharma (ANDA215266). Cross-references to other label sections are left out.

LEXETTE® is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

Source: DailyMed label, set id 8aa1f819-c81f-4af1-aaa7-353df3203ff6, version 1, effective May 31, 2025. NDC 51862-618, one of 2 listings for this product.

Questions

What is halobetasol propionate used for?

The FDA label says: “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. ...”

What drug class is halobetasol propionate?

FDA lists halobetasol propionate in the Corticosteroid established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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