ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics, as well as rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, 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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:. This product is the combination of disclosing agent with rapidly acting anesthetic of short duration.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. Known hypersensitivity to any component of this product.

DESCRIPTION SECTION.

FOR USE IN THE EYES ONLYDESCRIPTION:. Flourescein Sodium and Benoxinate Hydrochloride Opthalmic Solution USP, 0.25%/0.4% is 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.

DOSAGE & ADMINISTRATION SECTION.

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

HOW SUPPLIED SECTION.

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

INACTIVE INGREDIENT SECTION.

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%.

INDICATIONS & USAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRECAUTIONS SECTION.

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.

STORAGE AND HANDLING SECTION.

STORAGE AND HANDLING:. Store in refrigerator at 2-8C (36-46F). 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 REACH OF CHILDREN.

WARNINGS SECTION.

WARNINGS:. Prolonged use of topical ocular anesthetic is not recommended. It may produce permanent cornealopacification 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.