Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED SYNALAR ® (fluocinolone acetonide) Ointment, 0.025% is supplied in 120 g Tube – NDC 43538-910-12 STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.; PRINCIPAL DISPLAY PANEL - 120 g Tube Carton R x Only NDC 43538-910-12 SYNALAR ® (fluocinolone acetonide) Ointment, 0.025% For Topical Use Only Not For Ophthalmic Use 120 g MEDIMETRIKS PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
- HOW SUPPLIED SYNALAR ® (fluocinolone acetonide) Ointment, 0.025% is supplied in 120 g Tube – NDC 43538-910-12 STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.
- PRINCIPAL DISPLAY PANEL - 120 g Tube Carton R x Only NDC 43538-910-12 SYNALAR ® (fluocinolone acetonide) Ointment, 0.025% For Topical Use Only Not For Ophthalmic Use 120 g MEDIMETRIKS PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
Overview
SYNALAR ® (fluocinolone acetonide) Ointment 0.025% 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: SYNALAR ® Ointment contains fluocinolone acetonide 0.25 mg/g in a white petrolatum USP vehicle. Chemical Structure
Indications & Usage
SYNALAR ® Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Dosage & Administration
SYNALAR ® Ointment 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. 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 the 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 Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria
Storage & Handling
STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.
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