PHYTOVET EFA MOUSSE- salicyloyl phytosphingosine liquid

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 Mousse

Active Ingredients: phytosphingosine salicyloyl 0.05%.

Inactive Ingredients: water, PEG-8 dimethicone, glycerine, polysorbate-80, squalane, sodium lactate, hydrolyzed oat protein, safflower seed oil, fragrance, aloe barbadensis (aloe vera) leaf extract, potassium sorbate, methylisothiazoline, citric acid.

Properties: PhytoVet EFA Mousse is a gentle, hypoallergenic, soap-free mousse for grooming and moisturizing without bathing. It contains emollients, fatty acids, and aloe vera to soothe and nourish the skin. PhytoVet EFA Mousse also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

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

Directions for use: Shake well before use. Brush the haircoat then apply product.  Apply every 3 days for 2 to 3 weeks or as directed by your veterinarian.

For localized application: Massage 1 to 2 pumps onto the problem area of the skin.  Do not rinse, let air dry. Once dry, brush the hair coat again.

For whole body application: Dispense 1 to 2 pumps onto your palm hand and massage onto the skin. Repeat as many times as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the hair coat again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

11-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired breeds.

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.

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 - 6.8 oz (200 mL) Bottle

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7213-1

PHYTOVET EFA MOUSSE

Phytosphingosine Salicyloyl 0.05%

Moisturizing mousse for dogs and cats

6.8 fl oz (200 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

SHAKE WELL BEFORE USE

INGREDIENTS AND APPEARANCE

PHYTOVET  EFA MOUSSE
salicyloyl phytosphingosine liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
SODIUM LACTATE (UNII: TU7HW0W0QT)
OATMEAL (UNII: 8PI54V663Y)
LINSEED OIL (UNII: 84XB4DV00W)
PALM OIL (UNII: 5QUO05548Z)
SAFFLOWER OIL (UNII: 65UEH262IS)
SQUALANE (UNII: GW89575KF9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7213-1	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/15/2017

Labeler - Henry Schein Animal Health (603750329)

Registrant - Ceva Sante Animale (261126049)