Halobetasol Propionate (Page 2 of 2)

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Halobetasol Propionate Ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Halobetasol Propionate Ointment in pediatric patients have not been established and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Of approximately 850 patients treated with Halobetasol Propionate Ointment in clinical studies, 21% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients; and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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:

15 g (NDC 0713-0758-15)

50 g (NDC 0713-0758-86)

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].


Manufactured for:

Cosette Pharmaceuticals, Inc.

111 Coolidge Street, South Plainfield, NJ 07080

GW 7304

Rev. 08/2019

8-0758ALMLNC2

Principal Display Panel

NDC 0713-0758-15

Halobetasol Propionate Ointment 0.05%

15 g

Rx only

FOR TOPICAL USE ONLY. NOT FOR USE IN EYES.

Cosette Pharmaceuticals, Inc.

image description
(click image for full-size original)
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(click image for full-size original)

NDC 0713-0758-86

Halobetasol Propionate Ointment 0.05%

50 g

Rx only

FOR TOPICAL USE ONLY. NOT FOR USE IN EYES.

Cosette Pharmaceuticals, Inc.

image description
(click image for full-size original)
image description
(click image for full-size original)
HALOBETASOL PROPIONATE
halobetasol propionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0758
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
CETYL ALCOHOL
DIAZOLIDINYL UREA
GLYCERIN
ISOPROPYL PALMITATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
STEARETH-21
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0758-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0713-0758-15)
2 NDC:0713-0758-86 1 TUBE in 1 CARTON contains a TUBE
2 50 g in 1 TUBE This package is contained within the CARTON (0713-0758-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077109 05/21/2019 07/31/2023
Labeler — Cosette Pharmaceuticals, Inc. (116918230)
Registrant — Cosette Pharmaceuticals, Inc. (116918230)
Establishment
Name Address ID/FEI Operations
Cosette Pharmaceuticals, Inc. 116918230 analysis (0713-0758), manufacture (0713-0758), pack (0713-0758), label (0713-0758)

Revised: 04/2022 Cosette Pharmaceuticals, Inc.

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