HYDROCORTISONE OINTMENT USP, 1%

Rx only

For External Use Only

Not For Ophthalmic Use

Hydrocortisone Ointment USP, 1% contains hydrocortisone [Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11ß)-], with the molecular formula C₂₁H₃₀O₅ and molecular weight 362.47. Each gram contains 10 mg of hydrocortisone in a base containing white petrolatum and mineral oil.

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

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

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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 uled 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.

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

Topical corticosteroids are generally applied to the affected area as a thin film three or four 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.

Hydrocortisone Ointment USP, 1% is supplied as follows:

Store at controlled room temperature 15°-30°C (59°-86°F).

E. FOUGERA & CO
a division of Altana Inc.
MELVILLE, NEW YORK 11747
www.fougera.com

I22031B/IF22016B
R9/99
#230