Halonate Pac (Page 2 of 2)

Adverse Reactions to Halonate Pac

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.

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.

How Supplied

Halonate™ is supplied in the following:

(NDC 68712-042-01) one 50 g tube of halobetasol propionate ointment 0.05% packaged with one

4 oz can of ammonium lactate mousse 12%

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

Manufactured by:

G and W Laboratories, Inc.

South Plainfield, NJ 07080

Manufactured for:

Innocutis Holdings LLC

Charleston, SC 29401

1-800-499-4468

www.innocutis.com

Image of Carton
(click image for full-size original)

HALONATE PAC halobetasol ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-042
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
PENTAERYTHRITOL
PETROLATUM
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68712-042-01 50 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077721 05/01/2010
Labeler — Innocutis Holdings LLC (071501252)
Establishment
Name Address ID/FEI Operations
G &W Laboratories Inc. 001271188 manufacture

Revised: 11/2011 Innocutis Holdings LLC

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