Neo-Synalar Cream

Name: Neo-Synalar Cream

Neo-Synalar Cream Description

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.

Indications and Usage for Neo-Synalar Cream

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).

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.

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.

Neo-Synalar Cream Dosage and 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.

How is Neo-Synalar Cream Supplied

NEO-SYNALAR® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream is supplied in

  15 g Tube – NDC 43538-940-15   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).

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West, Fairfield, NJ 07004-2402 USA • www.medimetriks.com
Manufactured by: IGI Laboratories, Inc., Buena, NJ 08310

IP026
Iss. 4/14

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