PHYTO P ANTI-ITCH- pramoxine hydrochloride, 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 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 & USAGE

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.

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: 11695-7224-8

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)

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)

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)

INGREDIENTS AND APPEARANCE

PHYTO  P ANTI-ITCH
pramoxine hydrochloride, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	SALICYLOYL PHYTOSPHINGOSINE	0.5 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7224-8	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7224-6	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7224-1	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)