AlaCort

Name: AlaCort

AlaCort Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C21H30O5 and molecular weight is 362.47. Its structural formula is:

Each gram of ALA-CORT® (Hydrocortisone Cream USP) 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Each gram of ALA-CORT® (Hydrocortisone Cream USP) 2.5% contains 25 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Indications and Usage for AlaCort

Topcial corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topcial corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

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

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Packaging and storage

Store at 20o - 25oC (68o - 77oF) [see USP Controlled Room Temperature].

ALA-CORT (Hydrocortisone Cream USP), 1% -1oz Carton

NDC 0316-0126-01

Rx Only

ALA-CORT®

Hydrocortisone Cream USP, 1%

Warning: Keep out of reach of children.

For external use only.

Not for ophthalmic use.

1oz (28.4 grams)

Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube. Push cap until tube end is punctured. Screw cap back on to reseal tube.

Store at 20o-25oC (68o-77oF)[see USP Controlled Room Temperature].

Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information.

See end of carton for Lot Number and Expiration Date.

Manufactured and Distributed by:

Crown Laboratories, Inc. Johnson City, TN 37604

P7003.02

ALA-CORT (Hydrocortisone Cream USP), 2.5% - 30 grams tube

NDC 0316-0128-30

Rx Only

ALA-CORT®

Hydrocortisone Cream USP, 2.5%

Warning: Keep out of reach of children.

For external use only.

Not for ophthalmic use.

30 grams

Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information.

TO OPEN: Use cap to pucture seal. IMPORTANT: Do not use if seal has been puctured or is not visible.

Store at 20o-25oC (68o-77oF)[see USP Controlled Room Temperature].

See crimp of tube for Lot Number and Expiration Date.

Manufactured and Distributed by:

Crown Laboratories, Inc.

Johnson City, TN 37604

P2002.00

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