Halobetasol Propionate (Page 2 of 2)

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 Teligent Pharma, Inc. at 1-856-697-1441,
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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.

HOW SUPPLIED

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:
50 g (NDC 70512-033-50)

Manufactured by:
Sola Pharmaceuticals

Baton Rouge, LA 70809

Revised: 01/2019

STORAGE

Store Halobetasol Propionate Ointment between 15°C and 30°C (59°F and 86°F)

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC 70512-033-50

Halobetasol Propionate
Ointment, 0.05%

For topical use only.
Not for use in eyes.

Net Wt. 50 g
Rx Only

Sola Pharmaceuticals

HALOBETASOL PROPIONATE halobetasol propionate ointment ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70512-033 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOBETASOL PROPIONATE (HALOBETASOL) HALOBETASOL PROPIONATE 0.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength ALUMINUM STEARATE PETROLATUM PROPYLENE GLYCOL ALLYL PENTAERYTHRITOL SORBITAN SESQUIOLEATE MONOSTEARYL CITRATE YELLOW WAX

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70512-033-50 1 TUBE in 1 CARTON contains a TUBE 1 50 g in 1 TUBE This package is contained within the CARTON (70512-033-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209978 02/04/2019

Labeler — Sola Pharmaceuticals (080121345)

Revised: 01/2021 Sola Pharmaceuticals