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Tears Naturale II Polyquad (Alcon Laboratories, Inc.)

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SOLUTION/ DROPS 15 mL in 1 BOTTLE, DROPPER (0065-0418-15) Label Information

Complete Tears Naturale II Polyquad Information

  • OTC - ACTIVE INGREDIENT SECTION

    Dextran 70 0.1%
    Hypromellose 2910 0.3%


  • OTC - PURPOSE SECTION

    Lubricant


  • INDICATIONS & USAGE SECTION

    For the temporary relief of burning and irritation due to dryness 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 SECTION

    For external use only


  • OTC - DO NOT USE SECTION

    • if this solution changes color or becomes cloudy.
    • if you are sensitive to any ingredient in this product.

  • OTC - WHEN USING SECTION

    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.
    • Remove contact lenses before using.

  • OTC - STOP USE SECTION

    Stop use and ask a doctor if

    • you experience eye pain.
    • you experience changes in vision.
    • you experience continued redness or irritation of the eye.
    • the condition worsens or persists for more than 72 hours.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

    • Instill one or two drops in the affected eye(s) as needed.

  • OTHER SAFETY INFORMATION

    • Store at room temperature.

  • INACTIVE INGREDIENT SECTION

    POLYQUAD® (polyquaternium-1) 0.001%, potassium chloride, purified water, sodium borate and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.


  • OTC - QUESTIONS SECTION

    In the U.S. call 1-800-757-9195


  • PRINCIPAL DISPLAY PANEL

    Mild/Moderate Dry Eye

    NDC 0065-0418-15
    Soothing Comfort

    TEARS Naturale® II
    Polyquad®
    LUBRICANT EYE DROPS

    STERILE
    15 mL
    (0.5 FL OZ)

    Alcon®

    Carton

  • INGREDIENTS AND APPEARANCE
    TEARS NATURALE II POLYQUAD  
    dextran 70 and hypromellose 2910 solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0418
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 70 1 mg  in 1 mL
    Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35) Hypromellose 2910 (4000 Mpa.s) 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0065-0418-15 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 08/01/1990
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Laboratories, Inc. 008018525 MANUFACTURE(0065-0418)