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

  • 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 September 15, 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
    For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

  • 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

  • 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

  • STOP USE

    Stop use and ask a doctor if

    You experience eye pain, changes in vision, continued redness or irritation of the eye(s), or if the condition worsens or if 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°C to 25°C (68°F to 77°F)
    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.

  • QUESTIONS

    Questions or comments?

    Call toll-free +1-833-4HARROW (+1-833-442-7769)

  • PURPOSE

    FRESHKOTE® Preservative Free is the clear solution for the temporary relief of dry eye symptoms

  • PRINCIPAL DISPLAY PANEL

    HARROW

    FRESHKOTE®

    Preservative Free

    LUBRICANT EYE DROPS

    The clear solution

    Temporarily Relieves Symptoms of Dry Eye

    REFER TO FULL SAFETY INFORMATION PRIOR TO USE

    Sterile

    0.33 FL OZ (10mL)

    Temporary relief from dry eye

    Gentle, preservative-free drops can be used with contact lenses

    Exclusive patented formulation

    Unique phospholipid blend combats tear evaporation

    State-of-the-art Novelia® multidose bottle dispenses drop with precision

    FRESHKOTE®

    Preservative Free

    is the clear

    solution for the

    temporary relief of

    dry eye symptoms

    Product of France

    NDC 82667-013-10

    Carton Box

  • INGREDIENTS AND APPEARANCE
    FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS 
    povidone, polyvinyl alcohol solution solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82667-013
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED27 g  in 1000 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE20 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82667-013-101 in 1 BOX09/15/2023
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/15/2023
    Labeler - Harrow Eye, LLC (118526951)
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