PHYTOVET C 4%- chlorhexidine gluconate, phytosphingosine salicyloyl shampoo

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 C 4% SHAMPOO

Active Ingredients: chlorhexidine gluconate 4%, phytosphingosine salicyloyl 0.05%.

Inactive Ingredients: water, lauramine oxide, cocamidopropyl betaine, polyacrylate-1 crosspolymer, disodium oleamido MIPA-sulfosuccinate, decyl glucoside, glycolic acid, tetrasodium EDTA, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow #6.

Properties: PhytoVet C 4% Shampoo is a pleasantly scented shampoo designed for the antiseptic cleansing of the skin of dogs, cats and horses. It is soap-free and contains mild cleansing bases. PhytoVet C 4% Shampoo contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

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

Directions for Use: Wet the animal with cool water and massage the shampoo first on the areas with skin abnormalities, then on the rest of the body. Leave the shampoo on for 10 minutes then rinse with cool water. Use 2-3 times per week until symptoms subside or as directed by your veterinarian.

WARNINGS AND PRECAUTIONS

Cautions: For external use on dogs, cats and horses 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.

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 - 8 OUNCE (237 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7193-1

PHYTOVET C 4% SHAMPOO

Chlorhexidine Gluconate 4%,

Phytosphingosine Salicyloyl 0.05%

Antiseptic shampoo for dogs, cats
and horses

Net Contents: 8 fl oz (237 mL)

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7193-2

PHYTOVET C 4% SHAMPOO

Chlorhexidine Gluconate 4%,

Phytosphingosine Salicyloyl 0.05%

Antiseptic shampoo for dogs, cats
and horses

Net Contents: 16 fl oz (473 mL)

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 1 Gallon (3.785 L) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7193-3

PHYTOVET C 4% SHAMPOO

Chlorhexidine Gluconate 4%,

Phytosphingosine Salicyloyl 0.05%

Antiseptic shampoo for dogs, cats
and horses

Net Contents: 1 Gallon (3.785 L)

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

PHYTOVET  C 4%
chlorhexidine gluconate, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7193
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 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)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7193-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7193-2	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7193-3	3785 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 (603750329)

Registrant - Ceva Sante Animale (261126049)