Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NEO-SYNALAR ® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream is supplied in 60 g Tube – NDC 43538-940-60 STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).; PRINCIPAL DISPLAY PANEL - 60 g Tube Carton R x Only NDC 43538-940-60 NEO-SYNALAR ® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream 60 g For Topical Use Only Not For Ophthalmic Use MEDIMETRIKS PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
- HOW SUPPLIED NEO-SYNALAR ® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream is supplied in 60 g Tube – NDC 43538-940-60 STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton R x Only NDC 43538-940-60 NEO-SYNALAR ® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream 60 g For Topical Use Only Not For Ophthalmic Use MEDIMETRIKS PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
Overview
NEO-SYNALAR ® cream 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)-, and the antibacterial neomycin sulfate. Fluocinolone acetonide has the following chemical structure: The cream contains neomycin sulfate 5 mg/g (3.5 mg/g neomycin base) and fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax. Chemical Structure
Indications & Usage
NEO-SYNALAR ® cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS section) .
Dosage & Administration
NEO-SYNALAR ® cream is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Since NEO-SYNALAR ® cream is a water-washable vanishing cream, it is easily applied and leaves no traces.
Warnings & Precautions
WARNINGS If local infection should continue or become severe, or in the presence of systemic infection, appropriate systemic antibacterial therapy, based on susceptibility testing, should be considered. Because of the concern of nephrotoxicity and ototoxicity associated with neomycin, this combination product should not be used over a wide area or for extended periods of time. There are articles in the current medical literature that indicate an increase in the prevalence of persons sensitive to neomycin.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product should not be used in the external auditory canal if the eardrum is perforated.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids. 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 The following adverse reactions have been reported with the topical use of neomycin: Ototoxicity Nephrotoxicity
Storage & Handling
STORAGE Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).
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