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Tears Renewed Lubricant (Preferred Pharmaceuticals, Inc)

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SOLUTION 15 mL in 1 BOTTLE, DROPPER (68788-0039-1) Label Information

Complete Tears Renewed Lubricant Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Dextran 70 (0.1%)...........................................................(Lubricant)

    Hypromellose 2910 (0.3%)...............................................(Lubricant)


  • PURPOSE

    Uses

    • for the temporary relief of burning and irritation of the eye and for use as a protectant against further irritation.
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

  • WARNINGS

    Warnings

    For external use only.  Do not use: if this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.


  • WHEN USING

    When using this product

    • remove contact lenses before using
    • to avoid contamination, do not touch tip
    • replace cap after each use.

  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye gets worse or lasts more than 72 hours.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.


  • INDICATIONS & USAGE

    Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed.
    • Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzalkonium Chloride, Potassium Chloride, Disodium Chloride, Sodium Borate, Sodium Chloride, Boric Acid, Sterile Water, Purified Water, Sodium Chloride, and Sodium Citrate.


  • PRINCIPAL DISPLAY PANEL

    Tears Renewed Lubricant Eye Drops

    Relabeled By Preferred Pharmaceuticals, Inc
    Anaheim, CA 92807

    image of Tears Renewed label


  • DOSAGE & ADMINISTRATION

    Use as directed by your doctor or pharmacist


  • INGREDIENTS AND APPEARANCE
    TEARS RENEWED LUBRICANT 
    dextran 70 solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0039(NDC:17478-061)
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 0.001 mL  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES 0.003 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-0039-1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 11/16/2010
    Labeler - Preferred Pharmaceuticals, Inc (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc 791119022 relabel