Label: FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE- fluorescein sodium and proparacaine hydrochloride solution/ drops

  • NDC Code(s): 59390-205-05
  • Packager: Altaire Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 25, 2014

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  • DESCRIPTION:

    Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is a sterile ophthalmic solution combining the disclosing action of Fluorescein with the anesthetic action of  Proparacaine Hydrochloride.

    The active ingredient, Fluorescein Sodium, has the chemical name Spiro [isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one, 3' ,6' dihydroxy-,disodium salt.  It is represented by the following structural formula:

    The structural formula for Fluorescein Sodium

    The active ingredient, Proparacaine Hydrochloride, has the chemical name Benzoic acid, 3-amino-4-propoxy-, 2-[diethylamino]ethyl ester monohydrochloride.  It is represented by the following structural formula:

    The structural formula for Proparacaine Hydrochloride

    EACH mL CONTAINS: ACTIVES:  Fluorescein Sodium, USP, 0.25% [2.5 mg].  Proparacaine Hydrochloride, USP, 0.5% [5mg]; INACTIVES:  Povidone, Boric Acid, Water for Injection, Sodium Hydroxide, or/and Hydrochloric Acid may be added to adjust pH.
    PRESERVATIVE: Methylparaben 0.1%.

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  • ​CLINICAL PHARMACOLOGY

    This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.
    For procedures requiring a disclosing agent in combination with an 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 AND PRECAUTIONS

    WARNINGS:

    Avoid contamination - do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using. Prolonged use of a topical ocular anesthetic is not recommended. It may product permanent corneal opacification with accompanying visual loss.

    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 system stimulation followed by depression may occur. Protection of the eye from irritating 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.

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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 descementitis. 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.

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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.
    Deep Ophthalmic Anesthesia: 1 drop in each eye every 5 to 10 minutes for 5-7 doses.

    NOTE: The use of an eye patch is recommended.

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  • STORAGE:

    Store in refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to 1 month.

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  • HOW SUPPLIED:

    Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is supplied in a glass or plastic bottle with a controlled tip applicator in the following sizes:
    5 mL fill (glass bottle) with dropper

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  • SPL UNCLASSIFIED SECTION

    DO NOT USE IS IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.

    KEEP OUT OF REACH OF CHILDREN

    FOR OPHTHALMIC USE ONLY

    Manufactured By:

    Altaire Phamacueticals, Inc.

    311 West Lane

    Aquebogue, NY 119311

    Tel: 631-722-5988

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  • INGREDIENTS AND APPEARANCE
    FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE 
    fluorescein sodium and proparacaine hydrochloride solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59390-205
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN SODIUM 2.5 mg  in 1 mL
    PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X) PROPARACAINE HYDROCHLORIDE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONES (UNII: FZ989GH94E)  
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59390-205-05 1 in 1 CARTON
    1 5 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 06/14/2000
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
    Establishment
    Name Address ID/FEI Business Operations
    Altaire Pharmaceuticals Inc. 786790378 MANUFACTURE(59390-205)
    Establishment
    Name Address ID/FEI Business Operations
    Fagron GmbH & Co KG 316599554 RELABEL(59390-205)
    Establishment
    Name Address ID/FEI Business Operations
    Fagron Services B.V. 416169316 RELABEL(59390-205)
    Establishment
    Name Address ID/FEI Business Operations
    Siegfried Ltd 482824026 API MANUFACTURE(59390-205)
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