Label: BION TEARS- dextran, hypromellose solution/ drops

  • NDC Code(s): 0065-9305-01
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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

    Sodium chloride, potassium chloride, magnesium chloride hexahydrate, zinc chloride, calcium chloride dihydrate, sodium bicarbonate, purified water and carbon dioxide to adjust pH.

  • Questions?

    In the U.S. call 1-800-757-9195 or email
    alcon.medinfo@alcon.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 you were dissatisfied, to QA/Consumer Affairs, Alcon Laboratories, Fort Worth, TX 76134-2099. You will receive a full refund within 6 to 8 weeks.

    Manufactured for:
    Alcon
    Alcon Laboratories, Inc.
    Fort Worth, TX 76134-0109
    Made in France

    438230

    carton
  • INGREDIENTS AND APPEARANCE
    BION TEARS 
    dextran, hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-9305
    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
    Sodium Chloride (UNII: 451W47IQ8X)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Water (UNII: 059QF0KO0R)  
    Carbon Dioxide (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-9305-0128 in 1 CARTON04/01/2023
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01804/01/2023
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-9305)