TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.]

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  • TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.]

TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.]
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NDC 67510-0063-5
Set ID d98abe91-1967-4a07-9730-e98766912d68
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active Ingredient

    Glycerin 0.2%

    Hypromellose 0.2%

    Polyethylene Glycol 400 1%

  • Purpose

    Lubricant

    Lubricant

    Lubricant

  • Use

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for protection against further irritation
  • Warnings


    When using this product

    • remove contact lenses before using
    • do not use if this solution changes color or become 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 eye 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) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • Other information

    • store between 15° to 25°C (59°F to 77°F)


  • Inactive ingredients

    Ascorbic acid, benzalkonium chloride, boric acid, dextrose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

  • Package principal display panel

    Pureaid Artificial Tears

    carton

  • INGREDIENTS AND APPEARANCE
    TEARS LUBRICANT 
    glycerin, hypromelloses, polyethylene glycol 400 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0063
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0063-51 in 1 BOX05/30/2018
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34905/30/2018
    Labeler - Kareway Product, Inc. (121840057)
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