Flurox

Manufacturer
OCuSOFT, Inc.
Effective date
2019-11-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:01:45

Label at a glance#

ProductFlurox
Active ingredientFluorescein Sodium, Benoxinate Hydrochloride
Label structure12 sections

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.

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

Label contents#

Full prescribing information#

FOR USE IN THE EYES ONLYDESCRIPTION:

DESCRIPTION SECTION

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:
FL01FL01
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:

FL02FL02
Chemical Name: 2-(Diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride.

EACH mL CONTAINS:

INACTIVE INGREDIENT SECTION

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:

CLINICAL PHARMACOLOGY SECTION

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

INDICATIONS & USAGE:

INDICATIONS & USAGE SECTION

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:

CONTRAINDICATIONS SECTION

Known hypersensitivity to any component of this product.

WARNINGS:

WARNINGS SECTION

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:

PRECAUTIONS SECTION

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:

ADVERSE REACTIONS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

HOW SUPPLIED SECTION

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:

STORAGE AND HANDLING SECTION

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 ImageFlurox CM Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54799-508-05ML - Milliliter54799-5089d9503b4-17ce-4c94-83b8-0d07d7e1175a12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benoxinate HydrochlorideACTIVE INGREDIENT0VE4U49K151
Fluorescein SodiumACTIVE INGREDIENT93X55PE38X1
BenoxinateACTIVE MOIETYAXQ0JYM3031
FluoresceinACTIVE MOIETYTPY09G7XIR1
Boric AcidINACTIVE INGREDIENTR57ZHV85D41
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
PovidonesINACTIVE INGREDIENTFZ989GH94E1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54799-50854799-508-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 274 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBCREAM / TOPICAL38 mgExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBTABLET / ORAL2.32 mgExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION / ORAL100 mgExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / NASAL91.7 mg/100mlExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRASYNOVIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ORAL125 mgExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVENOUS18.25 mgExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBAEROSOL, METERED / RESPIRATORY (INHALATION)0.7 %w/wExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / AURICULAR (OTIC)0.37 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBTABLET, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSHAMPOO / TOPICAL104 mgExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBGEL, METERED / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS5 mgExact identifier — unii candidate
148 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBLOTION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4MOUTHWASH / BUCCAL7.36 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f70d5e3b-9437-42c8-babe-e8aac5bfc2c7900ec4c1-e5e3-e940-5b02-cf2589955e202022-05-23Warnings, Adverse reactionsExact identifier
spl set id: 900ec4c1-e5e3-e940-5b02-cf2589955e20

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.