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FLUOCINOLONE ACETONIDE TOPICAL
SOLUTION USP, 0.01%

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

Rx only

DESCRIPTION

Fluocinolone Acetonide Topical Solution USP, 0.01% 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 an empirical formula of C 24 H 30 F 2 O 6 and a molecular weight of 425.49 (CAS Registry Number 67-73-2).

Each mL of the topical solution contains 0.1 mg fluocinolone acetonide in a base containing propylene glycol and citric acid.

CLINICAL PHARMACOLOGY

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 the vasoconstrictor potency and therapeutic efficacy in man.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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

PRECAUTIONS

ADVERSE REACTIONS

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.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Fluocinolone Acetonide Topical Solution, USP 0.01% in 60 mL bottles,NDC 0168-0059-60

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

I259B
R4/04
#348

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