SUFFUSION TRIS FLUSH- ketoconazole, phytosphingosine hydrochloride solution

Suffusion by

Drug Labeling and Warnings

Suffusion by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resource, LTD., Ceva Sante Animale, Evonik Nutrition & Care GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Suffusion TRIS +PS FLUSH

ACTIVE INGREDIENTS: Ketoconazole 0.1%, Phytosphingosine HCl 0.01%.

INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Nonoxynol-9, Disodium EDTA, Tromethamine, Methylisothiazolinone.

PROPERTIES: Suffusion TRIS +PS Flush is an antibacterial and antifungal solution for the gentle cleansing of skin and ears. It contains ketoconazole for the management of yeast and fungal infections. TRIS +PS Flush helps break down bacteria cell walls. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

INDICATIONS & USAGE

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

DIRECTIONS FOR USE: Shake well before use. Apply twice a day or as directed by your veterinarian. Ask your veterinarian which of the following protocols is best for your pet.
Ear cleaning: 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. Skin cleaning: Apply liberally then use absorbent material to gently wipe away excess solution and debris. Repeat as necessary until clean. Do not allow animal to lick the treated area.

PRECAUTIONS

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. Wash hands after use.

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
www.pivetalvet.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

NDC: 46066-166-80

SUFFUSION™

TRIS +PS Flush

Ketoconazole 0.1%,

Phytosphingosine HCl 0.01%

Antiseptic Solution

FOR DOGS & CATS

Phytosphingosine

Wellness

BY PIVETAL 

4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC: 46066-166-91

SUFFUSION™

TRIS +PS Flush

Ketoconazole 0.1%,

Phytosphingosine HCl 0.01%

Antiseptic Solution

FOR DOGS & CATS

Phytosphingosine

Wellness

BY PIVETAL

16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  TRIS FLUSH
ketoconazole, phytosphingosine hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-166
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
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
NONOXYNOL-9 (UNII: 48Q180SH9T)
TROMETHAMINE (UNII: 023C2WHX2V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-166-80	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-166-91	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/04/2019

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)

Establishment
Name	Address	ID/FEI	Business Operations
Evonik Nutrition & Care GmbH		314906476	api manufacture