Suffusion TRIS FLUSH: Product Information

SUFFUSION TRIS FLUSH- ketoconazole and phytosphingosine hydrochloride solution
Aspen Veterinary Resource, LTD.

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.

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: 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.

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 CONDITIONS: Store at room temperature. Do not freeze.

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)

4 ounce bottle label
(click image for full-size original)

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)

16 ounce bottle label
(click image for full-size original)
SUFFUSION TRIS FLUSH
ketoconazole, phytosphingosine hydrochloride solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-166
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 1 mg in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (PHYTOSPHINGOSINE) PHYTOSPHINGOSINE HYDROCHLORIDE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
NONOXYNOL-9
TROMETHAMINE
EDETATE DISODIUM
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46066-166-80 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:46066-166-91 473 mL in 1 BOTTLE, PLASTIC None
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 Operations
Evonik Nutrition & Care GmbH 314906476 api manufacture

Revised: 09/2019 Aspen Veterinary Resource, LTD.

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