PHYTO KET- ketoconazole, phytosphingosine hydrochloride solution

Phyto by

Drug Labeling and Warnings

Phyto by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Phyto KET Antiseptic Flush

Active ingredients: Ketoconazole 0.1%, phytosphingosine HCI 0.01%.

Inactive ingredients: Water, SDA 40B 190 proof, nonoxynol-9, disodium EDTA, tromethamine, methylisothiazolinone.

Properties: Phyto KET antiseptic 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. It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier. Phytosphingosine HCl also has antiseptic properties.

INDICATIONS & USAGE

Indications: 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. 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 in the case of a suspected ruptured eardrum.

STORAGE AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

covetrus

11695-7222-4

Phyto KET

Ketoconazole 0.1%, 

phytosphingosine HCl 0.01%

Antiseptic Flush

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

For animal use only

Keep out of reach of children

Net Contents: 4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

covetrus

11695-7222-6

Phyto KET

Ketoconazole 0.1%,

phytosphingosine HCl 0.01%

Antiseptic Flush

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

For animal use only

Keep out of reach of children

Net Contents: 16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

PHYTO  KET
ketoconazole, phytosphingosine hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7222
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: 11695-7222-4	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7222-6	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2020

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)