EYE WASH (WATER) SOLUTION [KAREWAY PRODUCT, INC.]

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EYE WASH (WATER) SOLUTION [KAREWAY PRODUCT, INC.]
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NDC 67510-0662-4
Set ID 0bccbba8-091c-4d31-9f11-43e20d01977a
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredient

    Purified water (99.05%)

  • Purpose

    Eyewash

  • Uses

    washes the eye to help relieve

    • irritation
    • stinging
    • discomfort
    • itching;

    by removing

    • loose foreign material
    • air pollutants (smog or pollen)
    • chlorinated water
  • Warnings

    Do not use

    • if you have open wounds in or near the eyes, and get medical help right away

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists

    Keep out of reach of children.

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

  • Directions

    Remove contact lenses before using.

    • Do not touch tip of container to any surface to avoid contamination.
    • Replace cap after use.
    image without eye cup
    ------------------------------------------------------------------------------

    image with eye cup

    When using an eye cup

    • rinse the cup with Pure-aid Eye Wash immediately before each use
    • avoid contamination of the rim and inside surfaces of the cup
    • fill the cup half full with Pure-aid Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage
    • tilt the head backward. Open eyelids wide and rotate eyeball to thoroughly wash the eye
    • rinse cup with clean water after each use
  • Other information

    • store at room temperature
    • keep tightly closed
    • use before expiration date marked on the carton or bottle
  • Inactive ingredients

    boric acid, sodium borate, sodium chloride, Hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

  • Package label

    Advanced Eye Washimage of carton label

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0662
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0662-41 in 1 BOX
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/08/2011
    Labeler - Kareway Product, Inc. (121840057)
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