neomycin sulfate and fluocinolone acetonide
neomycin sulfate and fluocinolone acetonide is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Neo-Synalar. Available dosage form: cream.
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
- NEOMYCIN SULFATE, FLUOCINOLONE ACETONIDE
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.