Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinolone Acetonide Topical Solution USP, 0.01% 60 cc Bottle with applicator tip – NDC 43386-069-60 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0690600202 Rev. 06/2017; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Fluocinolone Acetonide Topical Solution, USP 0.01% For Topical Use Only Not for Ophthalmic Use Rx Only 60 mL- Container Label NDC 43386-069-60 Carton Label carton label container label
- HOW SUPPLIED Fluocinolone Acetonide Topical Solution USP, 0.01% 60 cc Bottle with applicator tip – NDC 43386-069-60 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0690600202 Rev. 06/2017
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Fluocinolone Acetonide Topical Solution, USP 0.01% For Topical Use Only Not for Ophthalmic Use Rx Only 60 mL- Container Label NDC 43386-069-60 Carton Label carton label container label
Overview
Fluocinolone Acetonide Topical Solution USP, 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 citric acid and propylene glycol. Chemical Structure
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 dressing 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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