T8 Keto Flush: Product Information

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.

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.
Shawnee, KS 66216

© 2020 Elanco or its affiliates

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

90197479 LV2011

Principal Display Panel – 118 mL Bottle Label

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)

T8 KETO FLUSH ketoconazole solution

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ketoconazole (Ketoconazole) Ketoconazole 1 mg in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID SODIUM HYDROXIDE WATER TROMETHAMINE HYDROCHLORIDE TROMETHAMINE TYLOXAPOL PROPYLENE GLYCOL BENZYL ALCOHOL CELLULOSE, MICROCRYSTALLINE EDETATE SODIUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58198-0013-1 1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC contains a BOTTLE, PLASTIC 1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOTTLE, PLASTIC (58198-0013-1) 2 NDC:58198-0013-2 1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC contains a BOTTLE, PLASTIC 2 355 mL in 1 BOTTLE, PLASTIC This package is contained within the BOTTLE, PLASTIC (58198-0013-2)

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)

Establishment
Name	Address	ID/FEI	Operations
Tropichem Research Labs, LLC dba Vetio		603123068	MANUFACTURE, PACK, LABEL, ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Piramal Pharma Limited		919067108	API MANUFACTURE

Revised: 03/2021 Elanco US Inc.