VETRASEB M- chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo

VETRASEB by

Drug Labeling and Warnings

VETRASEB by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Ceva Sante Animale, Lab Express International, Evonik Nutrition and Care GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

VetraSeb™ M 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: VetOne® VetraSebTM M Shampoo combines the unique properties of Phytosphingosine with antibacterial and antifungal agents for management of skin conditions.

INDICATIONS & USAGE

INDICATIONS: For use on dogs and cats only. For the 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 and cats 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.

WARNING: Keep out of the reach of children.

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by: MWI
Boise, Idaho 83705
www.VetOne.net
Questions?
1-800-999-0297

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC: 3985-726-08

VETONE®

VetraSeb™ M

Shampoo

Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%,

Phytosphingosine salicyloyl 0.05%

Antibacterial and Antifungal Shampoo +PS

for Dogs and Cats

For veterinary use only

Phytosphingosine

Net Contents: 8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC: 3985-726-16

VETONE®

VetraSeb™ M

Shampoo

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

Antibacterial and Antifungal Shampoo +PS
for Dogs and Cats

For veterinary use only

Phytosphingosine

Net Contents: 16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

VETRASEB  M
chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-726
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 CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-726-08	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 13985-726-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2017

Labeler - MWI/VetOne (019926120)

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