Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Cream USP, 2.5% 20 g (0.7 oz) tube NDC 0472-0337-20 30 g (1.1 oz) tube NDC 0472-0337-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0472-0337-20 Hydrocortisone Cream USP 2.5% Rx Only For External Use Only Not for Ophthalmic Use 20g (0.7 oz) image
- HOW SUPPLIED Hydrocortisone Cream USP, 2.5% 20 g (0.7 oz) tube NDC 0472-0337-20 30 g (1.1 oz) tube NDC 0472-0337-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0472-0337-20 Hydrocortisone Cream USP 2.5% Rx Only For External Use Only Not for Ophthalmic Use 20g (0.7 oz) image
Overview
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone cream is a member of this class. Hydrocortisone cream contains the synthetic steroid hydrocortisone (Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11ß)-) which has a molecular formula of C 21 H 30 O 5 , a molecular weight of 362.46 and CAS Registry Number 50-23-7. Each gram of the 2.5% cream contains 25 mg of hydrocortisone, USP in a cream base of cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax and citric acid solution and sodium citrate solution to adjust pH. chem structure
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 2 to 4 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 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. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
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