Label: ISOPTO TEARS- hypromellose 2910 solution

  • NDC Code(s): 0998-0408-15
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 14, 2023

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  • OTC - ACTIVE INGREDIENT SECTION

    Hypromellose 2910 0.5%

  • OTC - PURPOSE SECTION

    Lubricant

  • INDICATIONS & USAGE SECTION

    Uses

    • For the temporary relief of burning and irritation due to dryness of the eye.
    • For use as a protectant against further irritation.
  • WARNINGS SECTION

    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.
  • OTC - WHEN USING SECTION

    When using this product

    • Remove contact lenses before using.
    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after each use.
  • 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
    • the condition worsens or persists for 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 INFORMATION

    • Store at room temperature.
  • INACTIVE INGREDIENT SECTION

    Benzalkonium chloride 0.01% as preservative, dibasic sodium phosphate, monobasic sodium phosphate, purified water, sodium chloride, sodium citrate.

  • OTC - QUESTIONS SECTION

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

  • PRINCIPAL DISPLAY PANEL

    Alcon®

    Isopto® Tears
    LUBRICANT
    Eye Drops
    Hypromellose (Ophthalmic Solution)

    For Relief of Dry Eyes
    STERILE
    15 mL (1/2 FL OZ)

    TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

    Alcon®
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA

    World's largest manufacturer of ophthalmic preparations


    ©2000, 2010 Alcon, Inc.
    Printed in USA


    9001579-0410

    Carton
  • INGREDIENTS AND APPEARANCE
    ISOPTO TEARS 
    hypromellose 2910 solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0998-0408
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35) Hypromellose 2910 (4000 Mpa.s)5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Sodium Phosphate, Dibasic (UNII: GR686LBA74)  
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0998-0408-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/30/199012/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01809/30/199012/31/2024
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research Ltd007672236MANUFACTURE(0998-0408)
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