PHYTOVET KET FLUSH- ketoconazole, phytosphingosine hydrochloride solution

PHYTOVET by

Drug Labeling and Warnings

PHYTOVET by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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 & USAGE

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.

PRECAUTIONS

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 AND HANDLING

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

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

PHYTOVET  KET FLUSH
ketoconazole, phytosphingosine hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7201
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: 11695-7201-1	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7201-2	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/30/2017

Labeler - Henry Schein Animal Health (017880659)

Registrant - Ceva Sante Animale (261126049)