PHYTOVET EFA- 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 EFA SHAMPOO

Active Ingredients: phytosphingosine salicyloyl 0.02%.

Inactive Ingredients: water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, sodium chloride, sodium lactate, fragrance, glycerin, disodium cocoamphodiacetate, propylene glycol, hydroxypropyl methylcellulose, citric acid, tetrasodium EDTA, carthamus tinctorius (safflower) seed oil, methylchloroisothiazolinone, methylisothiazolinone.

Properties: PhytoVet EFA Shampoo is a gentle hypoallergenic, soap-free shampoo for grooming and moisturizing. It contains emollients and fatty acids to soothe and nourish the skin and aid in the control of flaking and skin irritations. PhytoVet EFA Shampoo also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

Indications: For use on dogs, cats and horses only. For grooming and moisturizing of dry or sensitive skin.

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.

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 fl oz (237 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7199-1

PHYTOVET EFA SHAMPOO

Phytosphingosine salicyloyl 0.02%

Moisturizing shampoo for dogs, cats and horses

8 fl oz (237 mL)

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7199-2

PHYTOVET EFA SHAMPOO

Phytosphingosine salicyloyl 0.02%

Moisturizing shampoo for dogs, cats and horses

16 fl oz (473 mL)

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 1 GALLON (3.785 L)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7199-3

PHYTOVET EFA SHAMPOO

Phytosphingosine salicyloyl 0.02%

Moisturizing shampoo for dogs, cats and horses

1 Gallon

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

PHYTOVET  EFA
phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.2 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)
SODIUM LACTATE (UNII: TU7HW0W0QT)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSES (UNII: 3NXW29V3WO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SAFFLOWER OIL (UNII: 65UEH262IS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7199-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7199-2	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7199-3	3785 mL in 1 JUG

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)