Label: TEARS NATURALE FORTE - dextran 70, glycerin and hypromelloses solution/ drops 

  • Label RSS
  • NDC Code(s): 0065-0426-22
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/09

If you are a consumer or patient please visit this version.

  • OTC - ACTIVE INGREDIENT SECTION

    Active Ingredients

    Dextran 70 0.1%
    Glycerin 0.2%
    Hypromellose 0.3%

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  • OTC - PURPOSE SECTION

    Purpose

    Lubricant

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  • 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.

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  • WARNINGS SECTION

    Warnings

    For external use only

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  • 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
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  • 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
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  • 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
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  • 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.

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  • DOSAGE & ADMINISTRATION SECTION

    Directions

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

    Other Information

    • store at room temperature.
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  • 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.

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  • OTC - QUESTIONS SECTION

    Questions?

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    TEARS NATURALE FORTE  
    dextran 70, glycerin, hypromellose solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0065-0426
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
    Glycerin (Glycerin) Glycerin 2 mg  in 1 mL
    Hypromelloses (Hypromelloses) Hypromelloses 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid  
    Calcium Chloride  
    Glycine  
    Hydrochloric Acid  
    Sodium Hydroxide  
    Magnesium Chloride  
    Polidronium Chloride  
    Polysorbate 80  
    Potassium Chloride  
    Water  
    Sodium Chloride  
    Zinc Chloride  
    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)
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