Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Fluocinolone Acetonide Ointment USP, 0.025% 15 gram tubes, NDC 0168-0064-15 60 gram tubes, NDC 0168-0064-60 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I26415G R11/12 #296; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0064-15 Fougera ® FLUOCINOLONE ACETONIDE OINTMENT USP, 0.025% Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0064-15 Fougera ® Rx only FLUOCINOLONE ACETONIDE OINTMENT USP, 0.025% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: Keep out of reach of children. NET WT 15 grams Package label - Principal Display Panel - 15g Carton
- HOW SUPPLIED: Fluocinolone Acetonide Ointment USP, 0.025% 15 gram tubes, NDC 0168-0064-15 60 gram tubes, NDC 0168-0064-60 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I26415G R11/12 #296
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0064-15 Fougera ® FLUOCINOLONE ACETONIDE OINTMENT USP, 0.025% Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0064-15 Fougera ® Rx only FLUOCINOLONE ACETONIDE OINTMENT USP, 0.025% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: Keep out of reach of children. NET WT 15 grams Package label - Principal Display Panel - 15g Carton
Overview
Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid 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 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum. chemical structure
Indications & Usage
: Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
: Fluocinolone Acetonide ointment is generally applied to the affected area as a thin film three or four times daily depending on the severity of the condition. In the 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. Some plastic films may be flammable and due care should be exercised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation. 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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