AMCINONIDE CREAM USP, 0.1%

Rx Only

NOT FOR OPHTHALMIC USE
FOR DERMATOLOGIC USE ONLY

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Each gram of Amcinonide Cream USP, 0.1% contains: 1 mg of Amcinonide, Benzyl Alcohol 2%, Emulsifying Wax, Glycerin, Isopropyl Palmitate, Lactic Acid, Purified Water and Sorbitol Solution. Chemically, amcinonide is:

Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-, (11β, 16α).

Topical corticosteroids have anti-inflammatory, antipruritic 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 from two to three times daily depending on the severity of the condition.

Occlusive dressings may be a valuable therapeutic adjunct 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.

Amcinonide Cream USP, 0.1% (1 mg/g) is supplied as follows:

•  NDC 0168-0278-15 15 gram tubes
•  NDC 0168-0278-30 30 gram tubes
•  NDC 0168-0278-60 60 gram tubes

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

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

I2278
R10/01
#53