Label: FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE- povidone, polyvinyl alcohol 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 July 25, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients            Purpose

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

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

  • PURPOSE

    Uses

    • For use as a protectant to prevent 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 marked on container
    • Store at 20-25οC(68-77οF)
    • Retain this carton for future reference
  • 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.

  • INDICATIONS & USAGE

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE 
    povidone, polyvinyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15821-105
    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:15821-105-036 in 1 BOX06/29/2018
    15 in 1 POUCH
    10.3 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/29/2018
    Labeler - FOCUS Laboratories, Inc. (926378337)
    Establishment
    NameAddressID/FEIBusiness Operations
    ExcelVision274234566manufacture(15821-105) , pack(15821-105)
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