Drug Facts
Composition & Profile
Identifiers & Packaging
Hydrocortisone Cream USP, 1% 1 oz (28.4 g) tube NDC 0472-0321-26 Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid freezing. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020; 209
- Hydrocortisone Cream USP, 1% 1 oz (28.4 g) tube NDC 0472-0321-26 Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid freezing. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020
- 209
Overview
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone, USP is included in this class of synthetic corticosteroid. Chemically, hydrocortisone, USP is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)- its molecular formula is C21H30O5; its molecular weight is 362.46; its Chemical Abstract Service (CAS) registry number is 50-23-7; and its structural formula is: [dc8d39b0-figure-01] Each gram of Hydrocortisone Cream USP, 1% provides 10 mg of hydrocortisone, USP in a non-staining water washable cream base consisting of stearyl alcohol, glyceryl monostearate, polyoxyl 40 stearate, isopropyl palmitate, paraffin, sorbitan monostearate, glycerin, lactic acid, potassium sorbate and purified water.
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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, miliaria. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.