Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Cream USP, 1%, a white cream, is supplied as follows: NDC 0168-0015-31 28.35 g (1 Oz) Tubes NDC 0168-0015-16 453.6 g (1 lb) Jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 Rev.07/2024; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 G CONTAINER NDC 0168-0015-31 Hydrocortisone Cream USP, 1% For External Use Only Not For Ophthalmic Use FOUGERA ® Rx only Contains: 10 mg of hydrocortisone, USP per gram in a base containing glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Net Wt. 28.35 g (1 Oz) tube; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 G CARTON NDC 0168-0015-31 Rx only Hydrocortisone Cream USP, 1% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 28.35 g (1 Oz) carton
- HOW SUPPLIED Hydrocortisone Cream USP, 1%, a white cream, is supplied as follows: NDC 0168-0015-31 28.35 g (1 Oz) Tubes NDC 0168-0015-16 453.6 g (1 lb) Jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 Rev.07/2024
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 G CONTAINER NDC 0168-0015-31 Hydrocortisone Cream USP, 1% For External Use Only Not For Ophthalmic Use FOUGERA ® Rx only Contains: 10 mg of hydrocortisone, USP per gram in a base containing glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Net Wt. 28.35 g (1 Oz) tube
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 G CARTON NDC 0168-0015-31 Rx only Hydrocortisone Cream USP, 1% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 28.35 g (1 Oz) carton
Overview
Hydrocortisone Cream USP, 1% contains hydrocortisone [pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11ß)-], with the molecular formula C 21 H 30 O 5 and molecular weight 362.47. Each gram contains 10 mg of hydrocortisone, USP in a base containing glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid, and purified water. Structural Formula
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 two or three times a day 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.
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