PHYTO P ANTI-ITCH- pramoxine hydrochloride, 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 P Anti-itch Shampoo

Active Ingredients: Pramoxine HCI 1%, phytosphingosine salicyloyl 0.05%.

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

Properties: Phyto P anti-itch shampoo is formulated for the temporary relief of itching in dogs, cats, and horses. This low-lather formula contains pramoxine, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to soothe irritated skin. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

Indications: For the temporary relief of itching and skin irritations.

Directions for use: Use 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the areas with skin abnormalities. 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. Leave shampoo on for 10 minutes before rinsing with cool water. Follow bath with Phyto P anti-itch créme rinse. For a rinse-free solution between baths, ask your veterinarian about Phyto P spray or 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: 11695-7224-8

Phyto P

Pramoxine HCl 1%,

phytosphingosine salicyloyl 0.05%

Anti-Itch Shampoo

Soothing 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: 11695-7224-6

Phyto P

Pramoxine HCl 1%,

phytosphingosine salicyloyl 0.05%

Anti-Itch Shampoo

Soothing 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 (3.875 L)

covetrus

NDC: 11695-7224-1

Phyto P

Pramoxine HCl 1%,

phytosphingosine salicyloyl 0.05%

Anti-Itch Shampoo

Soothing 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  P ANTI-ITCH
pramoxine hydrochloride, phytosphingosine salicyloyl shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE0.5 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OATMEAL (UNII: 8PI54V663Y)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7224-8237 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7224-6473 mL in 1 BOTTLE, PLASTIC
3NDC:11695-7224-13785 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: 4e883589-c5d9-429e-b448-1dc0bdfe5de2
Set id: 5a6b33aa-803f-4b99-af2d-146661728b04
Version: 1
Effective Time: 20191204
 
Butler Animal Health Supply, LLC dba Covetrus North America