Label: EYE WASH- water solution

  • 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 February 22, 2013

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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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