Label: EYS EYE WASH- water solution

  • NDC Code(s): 57349-220-04, 57349-220-15
  • Packager: Eyes-Plus LLC
  • 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Purified Water USP 98.4%

  • Purpose

    Eyewash

  • Use

    For cleansing the eye to help relieve irritation by removing loose foreign material

  • Warnings

    • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard
    • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor
    • Obtain immediate medical treatment for all open wounds in or near the eyes If solution changes color or becomes cloudy do not use

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

  • Other information

    • Store at 41° to 85°F
    • Do not use if top is broken or missing
  • Inactive ingredients

    boric acid, sodium borate, sodium chloride, sorbic acid

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Part# EyS-4

    Eyes-PlusLLC

    EyS

    Sterile Buffered Isotonic Solution
    Eye Wash
    Cleans, Refreshes
    & Sooths

    4 FL Oz (118mL)
    Single Use

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    EYS EYE WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57349-220
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water14.85 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric Acid (UNII: R57ZHV85D4)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sorbic Acid (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57349-220-1515 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product09/01/2020
    2NDC:57349-220-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/01/2020
    Labeler - Eyes-Plus LLC (078751656)
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