FLUOCINOLONE ACETONIDE CREAM, USP
0.01%, 0.025%

For Dermatologic Use Only - Not for Ophthalmic Use.

Rx Only

Fluocinolone Acetonide Cream contains Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)-bis(oxy)]-, (6α,11β,16α)-); it has a empirical formula of C ₂₄ H ₃₀ F ₂ O ₆ and a molecular weight of 452.49 (CAS Registry Number 67-73-2).

Each gram of the 0.01% cream contains 0.1 mg of Fluocinolone Acetonide in a base containing Stearic Acid, Propylene Gycol, Sorbitan Monostearate and Monooleate, Polysorbate 60, Citric Acid, Methylparaben, Propylparaben and Purified Water.

Each gram of the 0.025% cream contains 0.25 mg of Fluocinolone Acetonide in a base containing Stearic Acid, Propylene Gycol, Sorbitan Monostearate and Monooleate, Polysorbate 60, Citric Acid, Methylparaben, Propylparaben and Purified Water.

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 (SeePRECAUTIONS ).

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

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

Avoid excessive heat. Protect from freezing.

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

I25815C
#43
R6/98