FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE (POVIDONE, POLYVINYL ALCOHOL) SOLUTION [FOCUS LABORATORIES, INC.]

FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE (POVIDONE, POLYVINYL ALCOHOL) SOLUTION [FOCUS LABORATORIES, INC.]
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NDC 15821-105-03
Set ID be2f3b44-f371-4504-86d3-292cc8dfa062
Category HUMAN OTC DRUG LABEL
Packager FOCUS Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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

    image descriptionimage descriptionimage description

  • 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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