PHYTO EFA- phytosphingosine salicyloyl shampoo

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 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: Phyto EFA moisturizing shampoo is for grooming and moisturizing dry or sensitive skin. Emollients and fatty acids hydrate and soothe the skin and help control dryness and irritations. This low-lather shampoo 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: Bathe as needed or as directed by your veterinarian. Wet the animal with lukewarm water from the neck down and apply shampoo. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Rinse with lukewarm water. For a rinse-free treatment between baths, ask your veterinarian about Phyto EFA moisturizing mousse.

PRECAUTIONS

Cautions: For external use on dogs, cats, and horses only. 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. Wash hands after use.

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 - 8 fl oz (237 mL)

covetrus

NDC: 11695-7230-8

Phyto EFA Shampoo

Phytosphingosine salicyloyl 0.02%

Moisturizing Shampoo

Moisturizing shampoo for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

covetrus

NDC: 11695-7230-8

Phyto EFA Shampoo

Phytosphingosine salicyloyl 0.02%

Moisturizing Shampoo

Moisturizing shampoo for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 1 GALLON (3.785 L)

covetrus

NDC: 11695-7230-1

Phyto EFA Shampoo

Phytosphingosine salicyloyl 0.02%

Moisturizing Shampoo

Moisturizing shampoo for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 1 gallon (3.785 L)

INGREDIENTS AND APPEARANCE

PHYTO  EFA
phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7230
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: 11695-7230-8	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7230-6	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7230-1	3785 mL in 1 JUG

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)