Label: FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops
- NDC Code(s): 24208-732-05
- Packager: Bausch & Lomb Incorporated
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated November 1, 2012
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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:
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
- INDICATIONS AND USAGE
- WARNINGS NOT FOR INJECTION- FOR TOPICAL OPHTHALMIC USE ONLY.
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 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.
Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is administered to a nursing woman.
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
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
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
Prod. No. 30107
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
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)