PHYTO KET- ketoconazole, phytosphingosine hydrochloride solution 
Butler Animal Health Supply, 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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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: 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. 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: Store at room temperature. Do not freeze.

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)

4 ounce bottle label

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)

16 ounce bottle label

PHYTO  KET
ketoconazole, phytosphingosine hydrochloride solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7222
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:11695-7222-4118 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7222-6473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 12/2019
Document Id: 69ba997c-0cf0-4d9e-8832-f4ef9f0ce15b
Set id: 5ea817e7-8d9f-40ba-b551-77a53e9a025d
Version: 1
Effective Time: 20191219
 
Butler Animal Health Supply, LLC dba Covetrus North America