FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]

FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]
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NDC 15821-101-15
Set ID 6397ebc5-0670-4dc0-8660-6c0f733e6fd1
Category HUMAN OTC DRUG LABEL
Packager FOCUS Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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)