Hydrocortisone Acetate Cream

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND 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.

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.

DESCRIPTION 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

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. ( See PRECAUTIONS )

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.