T8 KETO FLUSH- ketoconazole solution

T8 Keto Flush by

Drug Labeling and Warnings

T8 Keto Flush by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Tropichem Research Labs, LLC dba Vetio, Piramal Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 – 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)

INGREDIENTS AND APPEARANCE

T8 KETO FLUSH 
ketoconazole solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58198-0013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)	Ketoconazole	1 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-0013-1	1 in 1 BOTTLE, PLASTIC
1		118 mL in 1 BOTTLE, PLASTIC
2	NDC: 58198-0013-2	1 in 1 BOTTLE, PLASTIC
2		355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/18/2014

Labeler - Elanco US Inc. (966985624)