Label: WALGREENS ARTIFICAL TEARS FREE- dextran 70, hypromellose solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 July 17, 2015

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  • OTC - ACTIVE INGREDIENT SECTION

    Dextran 70 0.1%

    Hypromellose 0.3%

  • OTC - PURPOSE SECTION

    Lubricant

    Lubricant

  • INDICATIONS & USAGE SECTION

    • For the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.
    • For use as a protectant against further irritation or to relieve dryness of the eye.

  • WARNINGS SECTION

    For external use only

  • OTC - DO NOT USE SECTION

    • If this solution changes color or becomes cloudy.
    • If you are sensitive to any ingredient in this product.

  • OTC - WHEN USING SECTION

    • To avoid contamination, do not touch tip of container to any surface.
    • Remove contact lenses before using.
    • Do not reuse.
    • Once opened, discard.

  • OTC - STOP USE SECTION

    • you experience eye pain.
    • you experience changes in vision.
    • you experience continued redness or irritation of the eye.
    • the condition worsens or persists for more than 72 hours.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

    • Instill one or two drops in the affected eye(s) as needed.

  • OTHER SAFETY INFORMATION

    • Store at room temperature 15° to 30°C (59° to 86°F).
    • Retain outer carton for full product drug facts.

  • INACTIVE INGREDIENT SECTION

    Potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • OTC - QUESTIONS SECTION

    1-800-883-0085

  • PRINCIPAL DISPLAY PANEL

    Sterile

    Artificial Tears

    Lubricant Eye Drops

    • Preservative free
    • Relieves dry, irriated eyes

    32 SINGLE-USE VIALS

    0.02FL OZ (0.6ML) EACH

    carton

  • INGREDIENTS AND APPEARANCE
    WALGREENS ARTIFICAL TEARS FREE 
    dextran 70, hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7746
    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)3 mg  in 1 mL
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7746-3232 in 1 CARTON
    10.6 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/16/2015
    Labeler - Walgreens (008965063)
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