Label: FLUROX (fluorescein sodium 2.5mg (0.25%), benoxinate hydrochloride 4mg- 0.4% solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

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:
    FL01
    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:

    FL02
    Chemical Name: 2-(Diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride.

  • EACH mL CONTAINS:

    ACTIVES: Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%)
    INACTIVES: Povidone, Boric Acid, Water For Injection. Hydrochloric Acid may be added to adjust pH (4.3 - 5.3).
    PRESERVATIVE: Methylparaben 0.1%

  • CLINICAL PHARMACOLOGY:

    This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.

  • INDICATIONS & USAGE:

    For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as
    tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

  • CONTRAINDICATIONS:

    Known hypersensitivity to any component of this product.

  • WARNINGS:

    Prolonged use of a topical ocular anesthetic is not recommended.  It may produce permanent corneal
    opacification with accompanying visual loss.  Avoid contamination - do not touch tip of sterile dropper
    used to dispense solution to any surface.  Replace container closure immediately after using.

  • PRECAUTIONS:

    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.

  • ADVERSE REACTIONS:

    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:

    Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 or 2 drops (in single instillations)
    in each eye before operating.

  • HOW SUPPLIED:

    Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied
    in a glass bottle with a sterilized dropper in the following size: 5mL

  • STORAGE AND HANDLING:

    Store in a refrigerator at 2°-8°C (36°-46°F).  Can be stored at room temperature for up to one month. 
    Keep tightly closed.
                    DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.
    KEEP OUT F REACH OF CHILDREN

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Flurox CM Image

  • INGREDIENTS AND APPEARANCE
    FLUROX  
    fluorescein sodium 2.5mg (0.25%), benoxinate hydrochloride 4mg (0.4%) solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54799-508
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fluorescein Sodium (UNII: 93X55PE38X) (Fluorescein - UNII:TPY09G7XIR) Fluorescein2.5 mg  in 1 mL
    Benoxinate Hydrochloride (UNII: 0VE4U49K15) (Benoxinate - UNII:AXQ0JYM303) Benoxinate Hydrochloride4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Boric Acid (UNII: R57ZHV85D4)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54799-508-055 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/29/2014
    Labeler - OCuSOFT, Inc. (174939207)