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Name:Hydrocortisone Acetate
Manufacturer:Cypress Pharmaceutical, Inc.
Category:Prescription Marketed Drugs

HYDROCORTISONE ACETATE   - hydrocortisone acetate gel 
Cypress Pharmaceutical, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


Hydrocortisone Acetate 2% with Aloe is a low potency topical gel containing: Hydrocortisone Acetate 2% in a base containing:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcoholi'i:arbomer, Dimethicone, Glycerin, PEG-7
Glyceryl Cocoate, Purified Water, Triethanolamine, Witch Hazel. Hydrocortisone Acetate 2% with Aloe contains a synthetic corticosteroid used as an anti-inflammatory. Hydrocortisone acetate Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1 mg/ 100 mL.

Topical corticosteroids share anti-inflammnatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokilletics: The extent of percutaneous absorption of topical corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or disease
processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings
substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings
may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND
ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are
bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver
and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also
excreted into the bile.

Hydrocortisone Acetate 2% with Aloe is a topical corticosteroid and is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. In pediatric patients absorption may result in higher blood levels and thus more susceptibility to systemic toxicity. (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Patients using topical corticosteroids should receive the following information
and instructions:
I. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. Do not use this medication for any disorder other than for which it has been prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a physician.
4. Report any signs of local adverse reactions especially under occlusive dressings.
5. Do not use any tight fitting diapers or plastic pants on a pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings.

The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test.

Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled
studies in pregnant women of teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on
pregnant patients, in large amounts, or for prolonged periods of time.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on
the infant. Caution should be exercised when any topical corticosteroids are administered to a nursing woman.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing's Syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitaIy-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 cortisone 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 pediatric patients.

Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of
decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately ·decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Apply to affected area 3 to 4 times daily. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

Hydrocortisone Acetate 2% with Aloe is supplied in 43 g tubes, (NDC 60258-048-43).
Store upright at controlled room temperature 15°-30°C (59°-86°F).


Unit Carton

hydrocortisone acetate with aloe gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60258-048
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone Acetate 2 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:60258-048-43 24 CARTON ( CARTON) in 1 CASE contains a CARTON
1 1 TUBE ( TUBE) in 1 CARTON This package is contained within the CASE (60258-048-43) and contains a TUBE
1 43 g in 1 TUBE This package is contained within a CARTON and a CASE (60258-048-43)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2007

Labeler - Cypress Pharmaceutical, Inc. (790248942)
Registrant - Harmony Labs, Inc. (105803274)
Name Address ID/FEI Operations
Harmony Labs, Inc. 105803274 manufacture, label, pack, relabel, repack

Revised: 06/2010 Cypress Pharmaceutical, Inc.

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2018 by Dionisios Fentas || Terms of Use


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