PHYTO EFA- phytosphingosine salicyloyl shampoo 
Butler Animal Health Supply, LLC dba Covetrus North America

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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: 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.

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: Store at room temperature. Do not freeze.

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)

8 ounce bottle label

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)

16 ounce bottle label

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)

1 Gallon Jug Label

PHYTO  EFA
phytosphingosine salicyloyl shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7230-8237 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7230-6473 mL in 1 BOTTLE, PLASTIC
3NDC:11695-7230-13785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 12/2019
Document Id: 8f412e3f-e656-457d-b927-10e4c68e6084
Set id: d608888d-f7e6-48b5-b643-4fb4c9c20c57
Version: 1
Effective Time: 20191217
 
Butler Animal Health Supply, LLC dba Covetrus North America