Label: ISOPTO TEARS- hypromellose 2910 solution

  • NDC Code(s): 0998-0408-15
  • 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 13, 2020

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

  • 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)

    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 Product09/30/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/30/1990
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research Ltd007672236MANUFACTURE(0998-0408)