Label: BION TEARS- dextran, hypromellose solution/ drops

  • NDC Code(s): 0065-0419-18, 0065-0419-28
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 7, 2019

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

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Dextran 70 0.1% Lubricant
    Hypromellose 2910 0.3% Lubricant
  • Uses

    • For use as a protectant against further irritation or to relieve dryness of the eye.

  • Warnings

    For external use only

  • Do not use

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

    • To avoid contamination, do not touch tip of container to any surface.
    • Do not touch unit-dose tip to eye.
    • Do not reuse. Once opened, discard.
  • Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness
    • irritation of the eye
    • symptoms worsening or persisting for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

    Store at room temperature.

  • Inactive Ingredients

    Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, zinc chloride, hydrochloric acid and/or sodium hydroxide and/or carbon dioxide to adjust pH.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Severe Dry Eye 

    Preservative-Free 

    BION® TEARS

    LUBRICANT EYE DROPS

    28 Single-Use Vials

    0.4 ml (0.015 FL OZ) Each

    STERILE

    Alcon®

    DIRECTIONS (HOW TO USE)

    Make sure container is intact before use.
    To open, COMPLETELY TWIST OFF TAB.
    Do not pull off.

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

    Throw away container.
    Do not reuse.
    Once opened, discard.
    All four containers within a pouch must be used within four days of opening the pouch.

    Tamper Evident: Containers are sealed in a protective foil pouch. Use only if foil pouch is undamaged at time of purchase.

    BION® TEARS Lubricant Eye Drops is an advanced tear substitute especially formulated and packaged for persistent dry eye conditions requiring frequent therapy.

    MONEY BACK GUARANTEED

    To fully assess comfort, a 3 to 4-week trial of BION® TEARS is recommended when switching from another brand of lubricant eye drops. If, however, you are not satisfied with the comfort BION® TEARS provides, we ask that you send the unused portion of the product and the sales receipt, with a brief description of why your were dissatisfied, to QA/Consumer Affairs, Alcon laboratories, Fort Worth, TX 76134-2099. You will receive a full refund within 6 to 8 weeks. U.S. Patent no. 5,403,598

    © 2003, 2005, 2006, 2009 Alcon, Inc.

    Manufactured for:

    Alcon®

    Alcon Laboratories, Inc.
    Fort Worth, TX 76134-0109
    Made in France
    9001814-0109
    41917

    Bion Tear Carton Image
  • INGREDIENTS AND APPEARANCE
    BION TEARS 
    dextran, hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0419
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 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 NameStrength
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Carbon Dioxide (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0419-2828 in 1 CARTON10/20/200012/21/2017
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:0065-0419-1828 in 1 CARTON10/20/2000
    20.4 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/19/1992
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-0419)