Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Cream USP, 2.5% Hydrocortisone Ointment USP, 2.5% a white cream is available as follows: a white ointment is available as follows: NDC 0168-0080-31 30 g Tubes NDC 0168-0146-30 28.35 g (1 oz) Tubes NDC 0168-0080-16 453.6 g (1 Lb) Jars NDC 0168-0146-16 453.6 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 – 1 OZ CONTAINER NDC 0168-0146-30 Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. Net Wt. 28.35 g (1 Oz) tube-ont; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CARTON NDC 0168-0146-30 Rx only Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 28.35 g (1 Oz) carton-ont; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CONTAINER NDC 0168-0080-31 Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Net Wt. 30 grams tube-crm; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CARTON NDC 0168-0080-31 Rx only Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 30 grams carton-crm
- HOW SUPPLIED Hydrocortisone Cream USP, 2.5% Hydrocortisone Ointment USP, 2.5% a white cream is available as follows: a white ointment is available as follows: NDC 0168-0080-31 30 g Tubes NDC 0168-0146-30 28.35 g (1 oz) Tubes NDC 0168-0080-16 453.6 g (1 Lb) Jars NDC 0168-0146-16 453.6 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 – 1 OZ CONTAINER NDC 0168-0146-30 Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. Net Wt. 28.35 g (1 Oz) tube-ont
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CARTON NDC 0168-0146-30 Rx only Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 28.35 g (1 Oz) carton-ont
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CONTAINER NDC 0168-0080-31 Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Net Wt. 30 grams tube-crm
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CARTON NDC 0168-0080-31 Rx only Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 30 grams carton-crm
Overview
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone Cream USP, 2.5% and Hydrocortisone Ointment USP, 2.5% contains hydrocortisone, USP. Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is: Molecular Formula: C 21 H 30 O 5 Molecular Weight: 362.47 Each gram of the 2.5% Cream contains 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Each gram of the 2.5% Ointment contains 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. chemical-structure
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply to the affected area as a thin film 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 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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