LUBRICANT EYE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WALGREENS]

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LUBRICANT EYE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WALGREENS]
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NDC 0363-6451-10
Set ID 1b02a39e-1960-2ca6-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART349
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Polyethylene Glycol 400 0.4%

    Propylene Glycol 0.3%

  • Purpose

    Lubricant

    Lubricant

  • Uses

    For the temporary relief of burning and irritation due to dryness of the eye.

  • Warnings

    For external use only.

  • Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • shake well before using
    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other information

    Store at room temperature.

  • Inactive ingredients

    benzalkonium chloride, boric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    1-800-883-0085

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Well at

    WALGREENS PHARMACIST RECOMMENDED≠

    STERILE

    Lubricant

    Eye Drops

    Polyethylene

    Glycol 400 0.4%

    Propylene Glycol 0.3%

    • For temporary relief of
      burning & irritation due
      to dryness of the eye

    Compare to Systane ® Ultra active ingredient#

    0.3 FL OZ (10 mL)

    carton

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6451
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6451-101 in 1 CARTON
    110 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 finalpart34907/16/2015
    Labeler - Walgreens (008965063)
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