FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops

Fluorescein Sodium and Benoxinate Hydrochloride by

Drug Labeling and Warnings

Fluorescein Sodium and Benoxinate Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action and short duration.

Fluorescein sodium is represented by the following structural formula:

C20H10Na2O5
Mol. Wt. 376.28

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:

C17H28N2O3 HCl
Mol. Wt. 344.88

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

Each mL Contains: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%), Benoxinate Hydrochloride 4 mg (0.4%); INACTIVES: Boric Acid, Povidone, Purified Water. Hydrochloric Acid may be added to adjust pH (4.3 – 5.3). PRESERVATIVE ADDED: Chlorobutanol 1%.

CLINICAL PHARMACOLOGY

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% 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- FOR TOPICAL OPHTHALMIC USE ONLY.

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

PRECAUTIONS

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% 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 system 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.

Pregnancy

Pregnancy Category C. Animal reproduction 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.

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

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 – NDC: 24208-732-05

Storage:

Store in a refrigerator at 2°-8°C (36°-46°F).

User may store at room temperature up to one month.

Keep tightly closed.

DO NOT USE IF IMPRINTED BODY SEAL IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: November 2012

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9117602 (Folded)

9117702 (Flat)

Prod. No. 30107

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC: 24208-732-05

BAUSCH + LOMB

Fluorescein Sodium and

Benoxinate Hydrochloride

Ophthalmic Solution USP,

0.25%/0.4%

(Sterile)

(with Sterilized Dropper)

5 mL

Rx only

9115101

AB30107

INGREDIENTS AND APPEARANCE

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE 
fluorescein sodium and benoxinate hydrochloride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 24208-732
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENOXINATE HYDROCHLORIDE (UNII: 0VE4U49K15) (BENOXINATE - UNII:AXQ0JYM303)	BENOXINATE HYDROCHLORIDE	4 mg  in 1 mL
FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)	FLUORESCEIN SODIUM	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-732-05	1 in 1 CARTON	01/01/1995
1		5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/1995

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-732)