SUFFUSION TRIS- ketoconazole solution 
ASPEN VETERINARY RESOURCES

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.

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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: 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.

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 CONDITIONS: Store at room temperature. Do not freeze.

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)

4 ounce bottle label

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)

16 ounce bottle label

SUFFUSION  TRIS
ketoconazole solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-079-88118 mL in 1 BOTTLE, PLASTIC
2NDC:46066-079-91473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/02/2021
Labeler - ASPEN VETERINARY RESOURCES (627265361)
Registrant - Ceva Sante Animale (261126049)

Revised: 4/2021
Document Id: 7439e294-6b36-4759-8283-1d648c2fe9de
Set id: bf0f6056-a94f-4ca1-8e7c-cfa2545d5d70
Version: 1
Effective Time: 20210402
 
ASPEN VETERINARY RESOURCES