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]

ACTIVE INGREDIENT:

Ketoconazole 0.1%.

INACTIVE INGREDIENTS: 

Water, SD Alcohol 40-B , Nonoxynol-9, Disodium EDTA, Tromethamine, Methylisothiazolinone, Ceramide NP, Ceramide AP, Phytosphingosine, Avena sativa (Oat) Kernel Extract, Ceramide EOP.

PROPERTIES:

A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. Suffusion™ 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 and cats for the antiseptic cleansing of skin and ears.

CAUTIONS:

For external use on dogs and cats only. Avoid contact with 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 with a suspected ruptured eardrum as directed by your veterinarian.

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 the entrance of the ear canal; OR
2) Hold ear flap upward and fill with solution as directed by your veterinarian.
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 visible debris and excess solution with a clean cotton ball. Wash hands after use.

WARNING:

Not for human use. Keep out of reach of children.

STORAGE CONDITIONS:

Store at room temperature. Do not freeze.

QUESTIONS?

info@aspenveterinaryresources.com

SPL UNCLASSIFIED SECTION

FOR DOGS & CATS

BREAKS DOWN
BACTERIA

Manufactured for:
Aspen Veterinary Resources®, LTD.
Liberty, MO 64068

pivetalvet.com

Packaging

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)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
OAT (UNII: Z6J799EAJK)
CERAMIDE 1 (UNII: 5THT33P7X7)

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)