Hydrocortisone Acetate Cream HYDROCORTISONE ACETATE ALLEGIS HOLDINGS LLC FDA Approved Hydrocortisone Acetate Cream USP is a topical preparation containing hydrocortisone acetate 2.5% w/w in a water washable cream base containing cetostearyl alcohol, ceteth 20, light mineral oil, petrolatum, propylparaben, butylparaben, citric acid, sodium citrate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredient is presented below: Structure
FunFoxMeds box
Route
TOPICAL
Applications
ANDA040396
Package NDC

Drug Facts

Composition & Profile

Strengths
2.5 % 28.4 g
Treats Conditions
Indications And Usage 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
UPC
0371297241019
UNII
3X7931PO74
Packaging

HOW SUPPLIED Hydrocortisone Acetate Cream 2.5% 1 oz (28.4 g) tube NDC 71297-241-01 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children. Keep tube closed when not in use. Rev 2/2025 Manufactured for: Allegis Holdings LLC Canton, MS 39046 Protected under U.S. Patent No. 5,635,497.; Label

Package Descriptions
  • HOW SUPPLIED Hydrocortisone Acetate Cream 2.5% 1 oz (28.4 g) tube NDC 71297-241-01 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children. Keep tube closed when not in use. Rev 2/2025 Manufactured for: Allegis Holdings LLC Canton, MS 39046 Protected under U.S. Patent No. 5,635,497.
  • Label

Overview

Hydrocortisone Acetate Cream USP is a topical preparation containing hydrocortisone acetate 2.5% w/w in a water washable cream base containing cetostearyl alcohol, ceteth 20, light mineral oil, petrolatum, propylparaben, butylparaben, citric acid, sodium citrate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredient is presented below: 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 areas as a thin film two to four times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the used 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 dressing. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions hypopigmentation, period dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.


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