Label: KOLLOURION EYESALVE EYEWASH- purified water 98.3% solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 14, 2023

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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(NDC:65785-160)
    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 DrugM01812/01/2020
    Labeler - Miracle Eye Pharmaceuticals (080055386)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miracle Eye Pharmaceuticals080055386repack(72924-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals Inc205477792manufacture(72924-001)
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