PHYTOVET KET FLUSH- ketoconazole, phytosphingosine hydrochloride solution 
Butler Animal Health, LLC dba Covetrus North America

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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PHYTOVET KET FLUSH

Active Ingredients: Ketoconazole 0.1%, Phytosphingosine HCl 0.01%.

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

Properties: PhytoVet KET Flush is an antiseptic (antibacterial and antifungal) solution for gentle cleansing and flushing of ears and skin. Contains ketoconazole for the management of yeasts and fungi, and preservatives for antibacterial activity. PhytoVet KET Flush contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier. Phytosphingosine HCl also has antiseptic properties.

Indications: For use on dogs, cats and horses only. For the antiseptic cleansing of skin and ears.

Directions for use: Shake well before use.

Skin cleaning: Apply liberally to the affected area(s). Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion.

Ear flushing: Instill liberally into the ear canal while keeping the ear flap up. Gently massage the base of the ear for a few seconds. Wipe the interior flap with cotton or gauze.

Apply twice daily or as directed by your veterinarian. Wash hands after use.

Cautions: For external use on dogs, cats and horses only. Avoid contact with the eyes. In case of contact with eyes, 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.

Storage Conditions: Store at room temperature. Do not freeze.

Questions? (855) 724-3461

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

11695-7201-1

PHYTOVET KET FLUSH

Ketoconazole 0.1%, Phytosphingosine HCl 0.01%

Antiseptic solution for cleansing and flushing of ears and skin for dogs, cats and horses

Net Contents: 4 fl oz (118 mL)

FOR ANIMAL USE ONLY
KEEP OUT OF THE REACH OF CHILDREN

4 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

11695-7201-2

PHYTOVET KET FLUSH

Ketoconazole 0.1%, Phytosphingosine HCl 0.01%

Antiseptic solution for cleansing and flushing of
ears and skin for dogs, cats and horses

Net Contents: 16 fl oz (473 mL)

FOR ANIMAL USE ONLY
KEEP OUT OF THE REACH OF CHILDREN

16 ounce bottle label

PHYTOVET  KET FLUSH
ketoconazole, phytosphingosine hydrochloride solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
TROMETHAMINE (UNII: 023C2WHX2V)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7201-1118 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7201-2473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/201708/12/2020
Labeler - Butler Animal Health, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 8/2020
 
Butler Animal Health, LLC dba Covetrus North America