Prescription Drug Information: Halobetasol Propionate (Page 2 of 2)

OVERDOSAGE

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

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 50g/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.

HOW SUPPLIED

Halobetasol propionate ointment, 0.05% is supplied in the following tube sizes:

15 g (NDC 45802-131-35) and 50 g (NDC 45802-131-32)

STORAGE

Store between 15°C and 30°C (59°F and 86°F).

MADE IN ISRAEL

MANUFACTURED BY PERRIGO, YERUHAM 80500, ISRAEL

DISTRIBUTED BY
PERRIGO ®
ALLEGAN, MI 49010

REV. 10/31/2011

Repacked By:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

: 9R500 RC J2

Principal Display Panel

Halobetasol Propionate Ointment, 0.05%

Rx Only

Halobetasol Propionate Ointment, 0.05% Carton Image #1
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Halobetasol Propionate Ointment, 0.05% Carton Image #1

HALOBETASOL PROPIONATE
halobetasol propionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-961(NDC:45802-131)
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
YELLOW WAX
PETROLATUM
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-961-50 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 50 g in 1 TUBE This package is contained within the CARTON (52959-961-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076872 02/05/2009
Labeler — H.J. Harkins Company, Inc. (147681894)
Registrant — Otsuka America Pharmaceutical, Inc. (008314390)
Establishment
Name Address ID/FEI Operations
Perrigo Nwe York Inc 078846912 manufacture

Revised: 12/2011 H.J. Harkins Company, Inc.

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