Label: LUBRICANT EYE- polyethylene glycol 400 and propylene glycol 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 July 16, 2015

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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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