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TEARS Naturale FORTE (Alcon Laboratories, Inc.)

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SOLUTION/ DROPS 15 mL in 1 BOTTLE, DROPPER (0065-0426-22) Label Information

Complete TEARS Naturale FORTE Information

  • OTC - ACTIVE INGREDIENT SECTION

    Active Ingredients

    Dextran 70 0.1%
    Glycerin 0.2%
    Hypromellose 0.3%


  • OTC - PURPOSE SECTION

    Purpose

    Lubricant


  • INDICATIONS & USAGE SECTION

    Uses

    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

    Warnings

    For external use only


  • OTC - DO NOT USE SECTION

    Do not use

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

  • OTC - WHEN USING SECTION

    When using this product

    • remove contact lenses before using
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

  • OTC - STOP USE SECTION

    Stop use and ask a doctor if

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

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


  • DOSAGE & ADMINISTRATION SECTION

    Directions

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

  • OTHER SAFETY INFORMATION

    Other Information

    • store at room temperature.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients

    Boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD® (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.


  • OTC - QUESTIONS SECTION

    Questions?

    In the U.S. call 1-800-757-9195
    www.tearsnaturale.com


  • PRINCIPAL DISPLAY PANEL

    Moderate/Severe Dry Eye

    NDC 0065-0426-22
    Dry Eye Protection

    TEARS Naturale® FORTE

    LUBRICANT EYE DROPS

    15 mL        
    (0.5 FL OZ)
    STERILE
    Alcon®

    Carton

  • INGREDIENTS AND APPEARANCE
    TEARS NATURALE FORTE  
    dextran 70, glycerin, hypromellose solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0426
    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
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 2 mg  in 1 mL
    Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO) Hypromelloses 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid (UNII: R57ZHV85D4)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Glycine (UNII: TE7660XO1C)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0065-0426-22 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 01/02/2003
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Laboratories, Inc. 008018525 MANUFACTURE(0065-0426)