Label: ALCON TEARS LUBRICANT EYE DROPS- hypromellose 2910 solution/ drops

  • NDC Code(s): 0065-0408-72
  • 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 June 20, 2022

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

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Hypromellose 2910 0.5%Lubricant
  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a protectant against further irritation
  • 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

    • remove contact lenses before using
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use
  • Stop use and ask a doctor if

    you experience any of the following:

    • eye pain
    • changes in vision
    • continued redness or irritation
    • condition worsens or persists for more than 72 hours
  • 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

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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Alcon Tears

    LUBRICANT
    Eye Drops

    For Relief of Dry Eye Symptoms

    STERILE


    15 mL (1/2 FL OZ)

    Alcon

    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

    Printed in USA

    Alcon Tears Carton
  • INGREDIENTS AND APPEARANCE
    ALCON TEARS LUBRICANT EYE DROPS 
    hypromellose 2910 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0408
    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, Unspecified Form (UNII: GR686LBA74)  
    Sodium Phosphate, Monobasic, Unspecified Form (UNII: 3980JIH2SW)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0408-721 in 1 CARTON03/01/2022
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/01/2022
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0408)