EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]

EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]
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NDC 67510-0663-1
Set ID 6018a680-374a-407c-9ef9-f5b01286383d
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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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