VETRASEB P- pramoxine hydrochloride, phytosphingosine shampoo

VetraSeb by

Drug Labeling and Warnings

VetraSeb by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

VetraSeb™ P Shampoo

Soothing Shampoo + PS for Dogs and Cats

ACTIVE INGREDIENTS: Pramoxine HCI 1%, Phytosphingosine salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Glycerin, Sodium Lactate, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Fragrance, Hydrolyzed Oat Protein, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES: VetraSeb™ P Shampoo is a pleasantly scented formulation designed for the temporary relief of itching in dogs and cats. It is soap-free and contains mild cleansing bases. VetraSeb™ P Shampoo contains Pramoxine, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to further soothe irritated skin. VetraSeb™ P Shampoo also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

INDICATION: For use on dogs and cats only. For the temporary relief of pruritus and skin irritations.

DIRECTIONS FOR USE: Wet the animal with warm water and apply VetraSeb™ P Shampoo. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed.

Apply 3 times per week for 2 to 3 weeks or as directed by your veterinarian. May be used as part of a management plan as recommended 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 the 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.

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC13985-730-08

VETONE®

VetraSeb™ P

Shampoo

Pramoxine HCI 1%,

Phytosphingosine salicyloyl 0.05%

Soothing 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

NDC13985-730-16

VETONE®

VetraSeb™ P

Shampoo

Pramoxine HCI 1%,

Phytosphingosine salicyloyl 0.05%

Soothing Shampoo + PS

for Dogs and Cats

For veterinary use only

Phytosphingosine

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

INGREDIENTS AND APPEARANCE

VETRASEB  P
pramoxine hydrochloride, phytosphingosine shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-730
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	SALICYLOYL PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
OATMEAL (UNII: 8PI54V663Y)
SAFFLOWER OIL (UNII: 65UEH262IS)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-730-08	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 13985-730-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2017

Labeler - MWI/VetOne (019926120)

Registrant - Ceva Sante Animale (261126049)