Label: FRESHKOTE LUBRICANT EYE DROPS- povidone/polyvinyl alcohol 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 October 31, 2018

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  • FreshKote Lubricant Eye Drops Doctor Recommended

  • SPL UNCLASSIFIED SECTION

    NDC 15821-101-15

    THE CLEAR SOLUTION

  • SPL UNCLASSIFIED SECTION

    Made in The USA

    Sterile 15mL (0.5 FL. OZ.)

  • SPL UNCLASSIFIED SECTION

    FreshKote Lubricant Eye Drops

  • Drug Facts

  • Active ingredients

    Active ingredients......................Purpose

    Polyvinyl pyrrolidone2.0%..............Lubricant

    Polyvinyl alcohol 2.7%....................Lubricant

  • PURPOSE

    Lubricant

  • Uses

    • For use as a lubricant to prevent 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

    For external use only.

    Do not use if:

    • solution changes color or becomes cloudy.
    • you are sensitive to any ingredient in this product.

    When using this product:

    • Do not touch tip of container to any surface to avoid contamination.
    • Replace cap after using.

    Stop use and ask a doctor if:

    • you experience eye pain.
    • you experience changes in vision.
    • you experience continued redness or irritation.
    • the 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.

  • Directions

    Instill 1 or 2 drop(s) in the affected eye(s) 3 or 4 times daily.

  • Other information

    • Store at 15 O-30 OC (58 O-86 OF)
    • Retain outer carton for full product drug facts.
  • Inactive ingredients:

    Boric acid, Disodium edetate dihydrate, Ethanol, Glycerin, Lecithin, Polixetonium, Polysorbate-80, Potassium chloride, Purified water, Sodium chloride

  • SPL UNCLASSIFIED SECTION

    Questions call toll-free 1-866-752-6006 www.freshkote.com

  • SPL UNCLASSIFIED SECTION

    Does Not Contain Benzalkonium Chloride

    DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    FOCUS Laboratories, Inc.

    North Little Rock, AR 72113

  • SPL UNCLASSIFIED SECTION

    Made in the USA

    FreshKote Lubricant Eye Drops

    INI0412 R0612

  • PRINCIPAL DISPLAY PANEL

    Product Carton

  • INGREDIENTS AND APPEARANCE
    FRESHKOTE LUBRICANT EYE DROPS 
    povidone/polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15821-101
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE K29/32 (UNII: 390RMW2PEQ) (POVIDONE K29/32 - UNII:390RMW2PEQ) POVIDONE K29/3220 g  in 1000 mL
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL27 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    POLIXETONIUM (UNII: EJT309W86C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15821-101-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/01/2006
    Labeler - FOCUS Laboratories, Inc. (926378337)
    Registrant - FOCUS Laboratories, Inc. (926378337)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altaire Pharmaceutical786790378analysis(15821-101) , label(15821-101) , manufacture(15821-101) , pack(15821-101) , sterilize(15821-101)
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