Label: FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE- 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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Drug Label Information

Updated November 1, 2012

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  • 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:

    Fluorescein Sodium 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:

    Benzoxinate Sodium 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%.

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  • 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.

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  • 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.

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  • CONTRAINDICATIONS

    Known hypersensitivity to any component of this product.

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  • 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.

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  • 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.

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  • 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

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  • 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.

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  • 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

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Fluorescein Sodium and Benox Hydrochloride Image

    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

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  • 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)  
    POVIDONES (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-732-05 1 in 1 CARTON
    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)
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