SUFFUSION TRIS- ketoconazole solution

Suffusion by

Drug Labeling and Warnings

Suffusion by is a Animal medication manufactured, distributed, or labeled by ASPEN VETERINARY RESOURCES, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Suffusion™ TRIS

FOR DOGS AND CATS

Ketoconazole 0.1%

ANTISEPTIC FLUSH

ACTIVE INGREDIENTS: Ketoconazole 0.1%.

INACTIVE INGREDIENTS: Water, SD Alcohol 40-B, Nonoxynol-9, Disodium EDTA, Tromethamine, Avena Sativa (Oat) Kernal Extract, Glycerin, Ceramide EOP, Ceramide EOS, Ceramide NP, Potassium Sorbate, Methylisothiazolinone.

PROPERTIES: A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. TRIS helps break down bacteria cell walls. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

INDICATIONS & USAGE

INDICATIONS: For use on dogs or cats for the antiseptic cleansing of skin and ears.

DIRECTIONS FOR USE: Skin Cleaning: Apply twice a day or as directed by your veterinarian. Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean. Wash hands after use.

Ear Cleaning: Ask your veterinarian which of these protocols is best for your pet. 1) Moisten a cotton ball with solution and place in entrance of ear canal; OR 2) Hold the ear flap upwards and fill the ear canal with solution.

Then, gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball. Wash hands after use.

PRECAUTIONS

CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use in the case of a suspected ruptured eardrum.

WARNING: Keep out of reach of children.

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

QUESTIONS? 1-800-999-0297

Pivetal

Distributed by:

Aspen Veterinary Resources®, LTD.

Liberty, MO 64068

pivetalvet.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

Pivetal

NDC: 46066-079-88

Suffusion™ TRIS

FOR DOGS AND CATS

Ketoconazole 0.1%

ANTISEPTIC FLUSH

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Pivetal

NDC: 46066-079-91

Suffusion™ TRIS

FOR DOGS AND CATS

Ketoconazole 0.1%

ANTISEPTIC FLUSH

16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  TRIS
ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-079
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
NONOXYNOL-9 (UNII: 48Q180SH9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROMETHAMINE (UNII: 023C2WHX2V)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-079-88	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-079-91	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/02/2021

Labeler - ASPEN VETERINARY RESOURCES (627265361)

Registrant - Ceva Sante Animale (261126049)