T8 KETO FLUSH- ketoconazole solution 
Elanco US Inc.

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.

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Elanco
T8 Keto™
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)

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
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)

Revised: 4/2023
Document Id: 7ab8dcba-7826-49c8-85ad-ef4ee1fff763
Set id: 2fff06d2-c883-4d8a-af7a-958b5fe9746f
Version: 2
Effective Time: 20230418
 
Elanco US Inc.