Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Fluocinolone Acetonide Topical Solution USP, 0.01% in 60 mL bottles, NDC 0168-0059-60. Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I259E R10/12 #348; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL CONTAINER NDC 0168-0059-60 Fougera ® FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% 60 mL FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL CARTON NDC 0168-0059-60 Fougera ® FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% 60 mL carton
- HOW SUPPLIED: Fluocinolone Acetonide Topical Solution USP, 0.01% in 60 mL bottles, NDC 0168-0059-60. Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I259E R10/12 #348
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL CONTAINER NDC 0168-0059-60 Fougera ® FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% 60 mL FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL CARTON NDC 0168-0059-60 Fougera ® FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% 60 mL carton
Overview
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. Each mL of the topical solution contains 0.1 mg fluocinolone acetonide in a water-washable base containing propylene glycol and citric acid. chemical-structure
Indications & Usage
: Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
: Fluocinolone Acetonide Solution is generally applied to the affected area as a thin film two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. 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.
Warnings & Precautions
No warnings available yet.
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 dressings. These reactions are listed 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.
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