Label: T8 KETO FLUSH- ketoconazole solution

  • NDC Code(s): 58198-0013-1, 58198-0013-2
  • Packager: Elanco US Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 18, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

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

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    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 Elanco US Inc.
    Greenfield, IN 46140

    DVM & Design, T8 Keto, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    © 2022 Elanco or its affiliates.

    Patent information at http://www.elancopatents.com

    90210013_YL600284A
    90210015_YL600284C

  • Principal Display Panel – 118 mL Bottle Label

    Elanco

    T8 KetoTM
    FLUSH

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

    CAUTION: Federal law restricts this drug to
    use by or on the order of a licensed veterinarian.

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

    Otic

    NET CONTENTS 118 mL (4 fl oz)

    Principal Display Panel - 118 mL Bottle Label
  • Principal Display Panel – 355 mL Bottle Label

    Elanco

    T8 KetoTM
    FLUSH

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

    CAUTION: Federal law restricts this drug to use by or on
    the order of a licensed veterinarian.

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

    Otic

    NET CONTENTS 355 mL (12 fl oz)

    Principal Display Panel - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    T8 KETO FLUSH 
    ketoconazole solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-0013
    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:58198-0013-11 in 1 BOTTLE, PLASTIC
    1118 mL in 1 BOTTLE, PLASTIC
    2NDC:58198-0013-21 in 1 BOTTLE, PLASTIC
    2355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/18/2014
    Labeler - Elanco US Inc. (966985624)