Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinolone Acetonide Topical Solution USP, 0.01% 60 mL Bottle with applicator tip - NDC 21922-003-01 STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). Store in an upright position. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Ind. Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 06 February 2022; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% NDC 21922-003-01 CARTON - 60mL FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% NDC 21922-003-01 BOTTLE - 60mL fluocinolone-acetonide-carton-label fluocinolone-acetonide-tube-label
- HOW SUPPLIED Fluocinolone Acetonide Topical Solution USP, 0.01% 60 mL Bottle with applicator tip - NDC 21922-003-01 STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). Store in an upright position. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Ind. Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 06 February 2022
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% NDC 21922-003-01 CARTON - 60mL FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% NDC 21922-003-01 BOTTLE - 60mL fluocinolone-acetonide-carton-label fluocinolone-acetonide-tube-label
Overview
Fluocinolone Acetonide Topical Solution, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1, 4-diene-3, 20-dione, 6, 9-difluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis (oxy)]-, (6α, 11β, 16α)-. It has the following chemical structure: Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of anhydrous citric acid and propylene glycol. structure.jpg
Indications & Usage
Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Fluocinolone Acetonide Topical Solution USP, 0.01% is generally applied to the affected area as a thin film from 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 Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation
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