T8 Keto Flush description, usages, side effects, indications, overdosage, supplying and lots more!

T8 Keto Flush

Bayer HealthCare LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
T8 Keto Flush

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Front Panel

NDC 0859-3014-01
NDC 0859-3014-02

T8 Keto®

Flush

Ketoconazole...........0.1% w/w

A Topical Antibacterial, Antifungal Formulation with Tris-EDTA for Dogs, Cats and Horses.

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

Active ingredient

Ketoconazole 0.1% w/w.

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 an antimicrobial preservative for antibacterial and antifungal activity.

Indications:

For gentle flushing and cleansing of skin and ears in such conditions where an antibacterial and antifungal formulation is indicated.

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 only.

Storage

Store at room temperature. Protect from freezing.

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

81583447, R.0 200108.00
81583439, R.0 200107.00

Package/4 fl oz Bottle Label Principal Display Panel

Package/4 fl oz Bottle Label Principal Display Panel

Package/12 x 4 fl oz Shipper Label Principal Display Panel

Package/12 x 4 fl oz Shipper Label Principal Display Panel

Package/12 fl oz Bottle Label Principal Display Panel

Package/12 fl oz Bottle Label Principal Display Panel

Package/12 x 12 fl oz Shipper Label Principal Display Panel

Package/12 x 12 fl oz Shipper Label Principal Display Panel

T8 Keto Flush

T8 Keto SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:0859-3014
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
KETOCONAZOLE KETOCONAZOLE 1 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0859-3014-02 118 in 1 BOTTLE, PLASTIC
2 NDC:0859-3014-01 355 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2014-02-18


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