PHYTOVET CK ANTISEPTIC MOUSSE- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid

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 CK ANTISEPTIC MOUSSE

Active Ingredients: chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.05%.

Inactive Ingredients: water, propylene glycol, glycerin, polysorbate 20, lactic acid, fragrance, methylisothiazolinone.

Properties: PhytoVet CK Antiseptic Mousse is a formulation designed to manage skin infections without bathing. It is soap-free, rubbing alcohol-free and moisturizing. PhytoVet CK Antiseptic Mousse also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

Indications: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and ketoconazole.

Directions for Use: Shake well before use.

For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area. Massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.

For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated.  Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

11-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired breeds.

Apply every 3 days for 2 to 3 weeks or as directed by your veterinarian.

WARNINGS AND PRECAUTIONS

Cautions: For external use on dogs and cats only. Avoid contact with 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. May be used as part of a management plan as recommended by your veterinarian.

STORAGE AND HANDLING

Storage: 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 - 6.8 fl oz (200 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7195-1

PHYTOVET CK

ANTISEPTIC MOUSSE

Chlorhexidine Gluconate 2%, Ketoconazole 1%,

Phytosphingosine Salicyloyl 0.05%

Antiseptic mousse for dogs and cats

6.8 fl oz (200 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

SHAKE WELL BEFORE USE

INGREDIENTS AND APPEARANCE

PHYTOVET  CK ANTISEPTIC MOUSSE
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7195-1	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2017

Labeler - Henry Schein Animal Health (603750329)

Registrant - Ceva Sante Animale (261126049)