T8 Keto Flush: Product Information

T8 KETO FLUSH- ketoconazole solution
Bayer HealthCare LLC

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.

Front Panel

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 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

©2019

LV1909

Package/4 fl oz Bottle Label Principal Display Panel

T8 Keto Flush 4 fl oz Bottle Label
(click image for full-size original)

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
t8 keto solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-3014
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-3014-02 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:0859-3014-01 355 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/18/2014
Labeler — Bayer HealthCare LLC (152266193)

Revised: 01/2021 Bayer HealthCare LLC

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