neomycin sulfate and fluocinolone acetonide

FDA Drug Profile — Neo-Synalar

Drug Details

Generic Name
neomycin sulfate and fluocinolone acetonide
Brand Names
Neo-Synalar
Application Number
ANDA060700
Sponsor
Eurofarma, Inc.
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
FLUOCINOLONE ACETONIDE, NEOMYCIN SULFATE

Indications and Usage

INDICATIONS AND 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) .

Warnings

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.