Label: FLUROX (fluorescein sodium 2.5mg (0.25%), benoxinate hydrochloride 4mg- 0.4% solution
- NDC Code(s): 54799-508-05
- Packager: OCuSOFT, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated November 12, 2019
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FOR USE IN THE EYES ONLYDESCRIPTION:
Flourescein Sodium and Benoxinate Hydrochloride Opthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action of short duration.
Fluorescein Sodium is represented by the following structural formula:
Chemical Name: Spiro [isobenzofuran-1 (3H),9'-[9H] xanthene]-3-one, 3',6' dihydroxy, disodium salt.
Benoxinate Hydrochloride is represented by the following structural formula:
Chemical Name: 2-(Diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride.
- EACH mL CONTAINS:
- CLINICAL PHARMACOLOGY:
- INDICATIONS & USAGE:
This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or
hyperthyroidism. The long-term toxicity is unknow; prolonged use may possible delay woundhealing. Although
exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity
manifested by central nervous sytem stimulation followed by depression may occur. Protection of the eye from
irritation, chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked
in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should
be advised to avoid touching the eye until the anesthsia has worn off.
Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics,
as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse
epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments
and someimes, iritis with descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988
- DOSAGE and ADMINISTRATION:
- HOW SUPPLIED:
- STORAGE AND HANDLING:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
fluorescein sodium 2.5mg (0.25%), benoxinate hydrochloride 4mg (0.4%) solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54799-508 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fluorescein Sodium (UNII: 93X55PE38X) (Fluorescein - UNII:TPY09G7XIR) Fluorescein 2.5 mg in 1 mL Benoxinate Hydrochloride (UNII: 0VE4U49K15) (Benoxinate - UNII:AXQ0JYM303) Benoxinate Hydrochloride 4 mg in 1 mL Inactive Ingredients Ingredient Name Strength Povidone, Unspecified (UNII: FZ989GH94E) Boric Acid (UNII: R57ZHV85D4) Hydrochloric Acid (UNII: QTT17582CB) Water (UNII: 059QF0KO0R) Methylparaben (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54799-508-05 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/29/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/29/2014 Labeler - OCuSOFT, Inc. (174939207)