Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Cream USP, 2.5% is available as follows: 20 g tube (NDC 68788-9922-2) 1 oz. (28 g) tube (NDC 68788-9922-2); Principal Display Panel - Hydrocortisone Cream USP, 2.5% NDC 68788-9922-2 Rx Only Hydrocortisone Cream USP, 2.5% NET WT 28 g Relabeled By: Preferred Pharmaceuticals Inc. Hydrocortisone Cream USP 2.5%
- HOW SUPPLIED Hydrocortisone Cream USP, 2.5% is available as follows: 20 g tube (NDC 68788-9922-2) 1 oz. (28 g) tube (NDC 68788-9922-2)
- Principal Display Panel - Hydrocortisone Cream USP, 2.5% NDC 68788-9922-2 Rx Only Hydrocortisone Cream USP, 2.5% NET WT 28 g Relabeled By: Preferred Pharmaceuticals Inc. Hydrocortisone Cream USP 2.5%
Overview
Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C 21 H 3O 0 5 ) and is represented by the following structural formula: Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemical Formula
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.
Dosage & Administration
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Warnings & Precautions
No warnings available yet.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
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 approximate 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, and miliaria.
Storage & Handling
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.
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