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Fluorescein and Benoxinate Ophthalmic Solution

Generic Name: fluorescein sodium and benoxinate hydrochloride
Dosage Form: ophthalmic solution

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.

Altaflour

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile) Rx Only

For Use in the Eyes Only

DESCRIPTION:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic 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:

Mol. Wt.= 376.27
C20H10Na2O5

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:

Mol. Wt.= 344.88
C17H28N2O3· HCl

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

EACH mL CONTAINS: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%), Benoxinate Hydrochloride 4 mg (0.4%); INACTIVES: Povidone, Boric Acid, Water for Injection. Hydrochloric Acid may be added to adjust pH (4.3-5.3). PRESERVATIVE: Chlorobutanol 1%.

CLINICAL PHARMACOLOGY:

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

INDICATIONS AND 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:

Not for Injection. Topical Use Only. 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 unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous systems 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 anesthesia 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 sometimes, 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 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C.

Animal reproductive studies have not been conducted with Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%. It is also not known whether Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

DOSAGE AND ADMINISTRATION:

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 to 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: 5 mL.

STORAGE:

Store in a refrigerator at 2°-8°C (36°-46°F), can be stored at room temperature for up to 1 month. Keep tightly closed.

FOR USE IN THE EYES ONLY.

DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.
KEEP OUT OF REACH OF CHILDREN

Rev. 05/2014                                    
MG #15857

                                         

Manufactured by:
[LOGO]
ALTAIRE PHARMACEUTICALS, INC.
Aquebogue, NY 11931 USA

PRINCIPAL DISPLAY PANEL

ALTAFLUOR
Fluorescein Sodium and
Benoxinate Hydrochloride
Ophthalmic Solution, USP
0.25%/0.4%
(Sterile)

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE 
fluorescein sodium and benoxinate hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59390-206
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENOXINATE HYDROCHLORIDE (BENOXINATE) BENOXINATE HYDROCHLORIDE 4 mg  in 1 mL
FLUORESCEIN SODIUM (FLUORESCEIN) FLUORESCEIN 2.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
POVIDONES  
BORIC ACID  
WATER  
HYDROCHLORIC ACID  
CHLOROBUTANOL  
Packaging
# Item Code Package Description
1 NDC:59390-206-05 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/21/2000
Labeler - Altaire Pharmaceuticals Inc. (786790378)
Establishment
Name Address ID/FEI Operations
Altaire Pharmaceuticals Inc. 786790378 MANUFACTURE(59390-206)
Revised: 05/2014
 
Altaire Pharmaceuticals Inc.



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