Label: WALGREENS ARTIFICIAL TEARS LUBRICANT EYE DROPS- dextran 70, hypromellose 2910 solution/ drops

  • 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 October 2, 2013

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

  • Drug Facts

    Active Ingredients                                           Purpose

    Dextran 70 0.1%.......................................... Lubricant

    Hypromellose 2910 0.3%............................... Lubricant

  • PURPOSE

    Uses

    • for the temporary relief of burning and irritation of the eye and for use as a protectant against further irritation.
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
  • WARNINGS

    Warnings

    For external use only. Do not use: if this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product

  • WHEN USING

    When using this product

    • remove contact lenses before using
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye gets worse or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poision Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • Instill 1 or 2 drops in the affected eye(s) as a needed
    • children under 6 years of age: ask a doctor.
  • STORAGE AND HANDLING

    Other Information

    • some users may experience a brief tingling sensation
    • store at 15° to 25°C (59° to 77°F)
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    benzalkonium chloride, boric acid, edetate disodium, potassium chloride, purified water, sodium borate, and sodium chloride

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILMOT RD.

    DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WALGREENS ARTIFICIAL TEARS LUBRICANT EYE DROPS 
    dextran 70, hypromellose 2910 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1678
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70.001 mg  in 1 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES.003 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1678-151 in 1 BOX
    115 mg in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/02/2013
    Labeler - Walgreens Company (008965063)