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 Teligent Pharma, Inc. at 1-856-697-1441,
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
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.
Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:
50 g (NDC 70512-033-50)
Baton Rouge, LA 70809
Store Halobetasol Propionate Ointment between 15°C and 30°C (59°F and 86°F)
For topical use only.
Not for use in eyes.
Net Wt. 50 g
|HALOBETASOL PROPIONATE halobetasol propionate ointment ointment|
|Labeler — Sola Pharmaceuticals (080121345)|
Revised: 01/2021 Sola Pharmaceuticals
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