Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 21922-064-04), 30 g (NDC21922-064-05), 60g (21922-064-07) and 120g (NDC21922-064-03) tubes. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Marcial, Panda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev.07/23; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL CARTON LABEL NDC- 21922- 064 -04 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 15 grams Rx only CARTON LABEL NDC- 21922- 064 -05 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 30 grams Rx only CARTON LABEL NDC- 21922- 064 -07 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 60 grams Rx only CARTON LABEL NDC- 21922- 064 -03 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 120 grams Rx only 15gm cart 30gm cart 60gm cart 120gm cart
- HOW SUPPLIED Fluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 21922-064-04), 30 g (NDC21922-064-05), 60g (21922-064-07) and 120g (NDC21922-064-03) tubes. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Marcial, Panda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev.07/23
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL CARTON LABEL NDC- 21922- 064 -04 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 15 grams Rx only CARTON LABEL NDC- 21922- 064 -05 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 30 grams Rx only CARTON LABEL NDC- 21922- 064 -07 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 60 grams Rx only CARTON LABEL NDC- 21922- 064 -03 Fluocinonide Cream USP, 0.05% For External Use Only. Not For Opthalmic Use. Net Wt 120 grams Rx only 15gm cart 30gm cart 60gm cart 120gm cart
Overview
Fluocinonide Cream USP, 0.05%, is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy) -6,9-difluoro-11-hydroxy-16,17-[(1 methylethylidene)bis(oxy)]-,(6a,11b,16a)-. It has the following chemical structure: Mol. Formula: C 26 H 32 F 2 O 7 Mol. Wt: 494.53 Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6 hexanetriol, polyethylene glycol-3350, polyethylene glycol- 8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non- staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. In the Fluocinonide Cream USP, 0.05%, formulation, the active ingredient is totally in solution. structure
Indications & Usage
Fluocinonide Cream USP, 0.05%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Fluocinonide Cream USP, 0.05%, is generally applied to the affected area as a thin film from two to 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.
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 preparations.
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 Miliaria 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
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