T8 KETO FLUSH (T8 KETO) SOLUTION [BAYER HEALTHCARE LLC]

T8 KETO FLUSH (T8 KETO) SOLUTION [BAYER HEALTHCARE LLC]
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NDC 0859-3014-01, 0859-3014-02
Set ID f364441d-59cf-406f-b037-c12f18383272
Category OTC ANIMAL DRUG LABEL
Packager Bayer HealthCare LLC
Generic Name
Product Class
Product Number
Application Number
  • Front Panel

    NDC 0859-3014-01
    NDC 0859-3014-02

    T8 Keto®

    Flush

    Ketoconazole...........0.1% w/w

    A Topical Formulation with Tris-EDTA for Dogs, Cats & Horses.

    WARNING: Keep out of reach of children
    Not For Human Use
    Otic

    Net Contents: 118 mL (4 fl oz)

    Net Contents: 355 mL (12 fl oz)

  • Key Ingredients:

    Contains Tris-EDTA and ketoconazole in a proprietary water-based formulation.

  • Product Description:

    T8 Keto® Flush is a patented, alkaline (pH 8.5), water-based formulation with mild surfactants for gentle cleansing and flushing. It contains ketoconazole, buffered chelating agents, and a preservative.

  • Indications:

    For gentle flushing and cleansing of skin and ears in such conditions as recommended by your veterinarian.

  • Directions:

    Shake well before use. Apply T8 Keto® Flush liberally to affected area(s). Use cotton or absorbent material to clean excess solution and debris. Apply twice daily or as directed by your veterinarian.

  • Cautions:

    For topical use on dogs, cats and horses. Avoid contact with eyes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and consult your veterinarian. Available through licensed veterinarians.

  • Storage:

    Store at room temperature. Protect from freezing.

    Manufactured for Bayer HealthCare, LLC,
    Animal Health Division, Shawnee Mission, KS 66201
    Made in Canada

    Bayer, the Bayer Cross, DVM & Design and T8 Keto are registered trademarks of Bayer.

    T8 Keto® is protected by the following U.S. patent: 7,928,147

  • Package/4 fl oz Bottle Label Principal Display Panel

    T8 Keto Flush 4 fl oz Bottle Label

    T8 Keto®
    Flush
    Ketoconazole…………….0.1% w/w

    A Topical Formulation with Tris-EDTA
    for Dogs, Cats & Horses

    WARNING: Keep out of reach of
    children. Not for Human Use

    Otic
    Net Contents: 118 mL (4 fl oz)

  • INGREDIENTS AND APPEARANCE
    T8 KETO FLUSH 
    t8 keto solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:0859-3014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0859-3014-02118 mL in 1 BOTTLE, PLASTIC
    2NDC:0859-3014-01355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/18/2014
    Labeler - Bayer HealthCare LLC (152266193)

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