Hydrocortisone Cream HYDROCORTISONE DIRECT_RX FDA Approved 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: [chemical-structure] Molecular Formula: C21H30O5 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.
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Substance Hydrocortisone
Route
TOPICAL
Applications
ANDA089414
Package NDC

Drug Facts

Composition & Profile

Strengths
2.5 % 30 g 28.35 g 453.6 g
Quantities
30 count
Treats Conditions
Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
WI4X0X7BPJ
Packaging

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 72189-625-30 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; 72189-625-30

Package Descriptions
  • 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 72189-625-30 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
  • 72189-625-30

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: [chemical-structure] Molecular Formula: C21H30O5 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.

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.

Storage & Handling

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


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