PHYTOVET MC- chlorhexidine gluconate, miconazole nitrate, 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, Lab Express International, Evonik Nutrition and Care GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

PHYTOVET MC SHAMPOO

Active Ingredients: chlorhexidine gluconate 2%, miconazole nitrate 2%, phytosphingosine salicyloyl 0.05%.

Inactive Ingredients: water, lauramine oxide, cocamidopropyl betaine, decyl glucoside, polyacrylate-1 crosspolymer, lactic acid, acetic acid, fragrance, methylchloroisothiazolinone, methylisothiazoline, sodium hydroxide.

Properties: PhytoVet MC Shampoo combines the unique properties of phytosphingosine with antibacterial and antifungal agents for management of skin conditions.

INDICATIONS & USAGE

Indications: For use on dogs, cats and horses only. For management of dermatological conditions associated with infections responsive to chlorhexidine gluconate and miconazole nitrate.

Directions for Use: Shake well before 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 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.

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 - 8 OUNCE (237 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

11695-7211-1

PHYTOVET MC SHAMPOO

Chlorhexidine Gluconate 2%, Miconazole

Nitrate 2%, Phytosphingosine Salicyloyl 0.05%

Antibacterial and antifungal shampoo for dogs,
cats and horses

8 fl oz (237 mL)

FOR ANIMAL USE ONLY
KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

11695-7211-2

PHYTOVET MC SHAMPOO

Chlorhexidine Gluconate 2%, Miconazole
Nitrate 2%, Phytosphingosine Salicyloyl 0.05%

Antibacterial and antifungal shampoo for dogs,
cats and horses

16 fl oz (473 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 1 Gallon (3785 mL) Jug

HENRY SCHEIN®

ANIMAL HEALTH

11695-7211-3

PHYTOVET MC SHAMPOO

Chlorhexidine Gluconate 2%, Miconazole
Nitrate 2%, Phytosphingosine Salicyloyl 0.05%

Antibacterial and antifungal shampoo for dogs,
cats and horses

1 Gallon (3.785 L)

FOR ANIMAL USE ONLY
KEEP OUT OF THE REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

PHYTOVET  MC
chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7211
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
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 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)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LACTIC ACID (UNII: 33X04XA5AT)
ACETIC ACID (UNII: Q40Q9N063P)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7211-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7211-2	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7211-3	3785 mL in 1 JUG

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)

Establishment
Name	Address	ID/FEI	Business Operations
Lab Express International		800875106	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Evonik Nutrition and Care GmbH		314906476	api manufacture