Label: EYE LUBRICANT- polyethylene gloycol, propylene glycol liquid

  • 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 21, 2012

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  • 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
    • for protection against further irritation

  • Warnings

    Enter section text here

    When using this product

    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • 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 eyes lasts
    • condition worsens or lasts more than 72 hours

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • Put 1 to 2 drops in the affected eye(s) as needed
    • children under 6 years of age: ask a doctor
  • Other information

    Store at 15 - 30ºC (59 - 86ºF)

  • Inactive ingredients

    benzalkonium chloride, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    Lubricant Eye Drops Ultraimage of carton label

  • INGREDIENTS AND APPEARANCE
    EYE LUBRICANT  
    polyethylene gloycol, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0663
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOLS - UNII:3WJQ0SDW1A) 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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0663-11 in 1 BOX
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/11/2012
    Labeler - Kareway Product, Inc. (121840057)
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