Label: KOLLOURION EYESALVE EYEWASH- purified water 98.3% solution

  • NDC Code(s): 72924-001-01
  • Packager: Miracle Eye Pharmaceuticals
  • 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 3, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Purified Water 98.3%

  • PURPOSE

    Purpose

    Eyewash

  • INDICATIONS & USAGE

    Use

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

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
    • if solution changes color or becomes cloudy

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • do not reuse
    • once opened, discard

    Stop use and ask a doctor if

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • continued redness or irritation of the eye
    • condition worsens or persists
    • eye pain
    • changes in vision

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
  • OTHER SAFETY INFORMATION

    Other information

    • lot number is printed on the bottle
    • store at 20° to 25° C [68° to 77° F]
    • for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"
    • do not use if this seal is missing or broken
    • use before expiration date marked on bottle
  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, sodium borate, sodium chloride

  • QUESTIONS

    Call 1-973-568-3361 9am to 5pm EST

  • PRINCIPAL DISPLAY PANEL

    label 2label 3label

  • INGREDIENTS AND APPEARANCE
    KOLLOURION EYESALVE EYEWASH 
    purified water 98.3% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72924-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER929 g  in 946 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72924-001-011 in 1 CARTON12/01/2020
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/01/2020
    Labeler - Miracle Eye Pharmaceuticals (080055386)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miracle Eye Pharmaceuticals080055386manufacture(72924-001)
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