Label: FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS- povidone, polyvinyl alcohol solution

  • NDC Code(s): 71776-001-03, 71776-001-10
  • Packager: Eyevance Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients            Purpose

    Polyvinyl Alcohol 2.7%.........Lubricant

    Povidone 2.0%....................Lubricant

  • INDICATIONS & USAGE

    Uses

    • For use as a lubricant to reduce further irritation or to relieve dryness of the eye
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use if

    • Seal is damaged
    • Solution changes color or becomes cloudy
    • You are sensitive to any ingredient in this product
  • STOP USE

    Stop use and ask a doctor if

    • You experience eye pain
    • You experience changes in vision
    • You experience continued redness or irritation
    • Condition worsens
    • Symptoms last more than 72 hours
  • 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

    Instill 1 or 2 drop(s) in the affected eye(s) as needed

  • STORAGE AND HANDLING

    Other information

    • Use before expiration date and discard bottle 30 days after opening
    • Store at 20-25 οC(68-77 οF)
    • Retain carton for reference
    • Do not freeze
  • INACTIVE INGREDIENT

    Inactive ingredients

    Boric acid, Edetate disodium, Ethanol, Glycerin, Phospholipids, Polysorbate 80, Potassium chloride, Purified water, Sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • PURPOSE

    Purpose

    For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

  • WHEN USING

    When using this product

    • Do not touch tip of container to any surface to avoid contamination
    • Replace cap after using
    • Shake off remaining drop before replacing cap
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS 
    povidone, polyvinyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71776-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE20 g  in 1000 mL
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED27 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71776-001-101 in 1 BOX03/13/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:71776-001-0330 in 1 BOX12/06/2020
    20.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01803/13/2019
    Labeler - Eyevance Pharmaceuticals (080876046)
    Establishment
    NameAddressID/FEIBusiness Operations
    ExcelVision274234566manufacture(71776-001) , pack(71776-001)
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