PHYTO EFA MOUSSE- salicyloyl phytosphingosine liquid

Phyto by

Drug Labeling and Warnings

Phyto by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Phyto EFA Moisturizing 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: Phyto EFA moisturizing mousse is for grooming and moisturizing dry or sensitive skin without bathing. Emollients and fatty acids hydrate and soothe the skin and help control dryness and irritation. This no-rinse mousse also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

Indications: For the management of dry, irritated, or sensitive skin.

Directions for use: Shake well before use. Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian.
For localized application: Dispense 1 to 2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.

For whole body application: Dispense 1 to 2 pumps onto your palm, then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur 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 only on dogs and cats. Avoid contact with eyes. If eye contact occurs, 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:

Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 6.8 oz (200 mL) Bottle

covetrus

NDC: 11695-7236-2

Phyto EFA

Phytosphingosine salicloyl 0.05%

Moisturizing mousse

Moisturizing mousse for dogs and cats

For animal use only

Keep out of reach of children

SHAKE WELL BEFORE USE

Net contents: 6.8 fl oz (200 mL)

INGREDIENTS AND APPEARANCE

PHYTO  EFA MOUSSE
salicyloyl phytosphingosine liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7236
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)
SAFFLOWER OIL (UNII: 65UEH262IS)
SQUALANE (UNII: GW89575KF9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7236-2	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2020

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)