PHYTOVET P ANTI-ITCH- pramoxine hydrochloride, phytosphingosine salicyloyl shampoo

PHYTOVET by

Drug Labeling and Warnings

PHYTOVET by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

PHYTOVET 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: PhytoVet P Anti-Itch Shampoo is a pleasantly scented formulation designed for the temporary relief of itching in dogs, cats and horses. It is soap-free and contains mild cleansing bases. PhytoVet P Anti-Itch Shampoo contains pramoxine, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to further soothe irritated skin. PhytoVet P Anti-Itch Shampoo also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

Indications: For use on dogs, cats and horses only. For the temporary relief of pruritus and skin irritations.

Directions for Use: Wet the animal with cool water and massage the shampoo first on the areas with skin abnormalities, then on the rest of the body. Leave the shampoo on for 10 minutes then rinse with cool water. Use 2-3 times per week until symptoms subside or as directed by your veterinarian.

PRECAUTIONS

Cautions: For external use on dogs, cats and horses only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

STORAGE AND HANDLING

Storage Conditions: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Questions? (855) 724-3461

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

PRINCIPAL DISPLAY PANEL - 8 fl oz (237 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7205-1

PHYTOVET P

ANTI-ITCH SHAMPOO

Pramoxine HCl 1%,

Phytosphingosine Salicyloyl 0.05%

Soothing shampoo for dogs, cats and horses

8 fl oz (237 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7205-2

PHYTOVET P

ANTI-ITCH SHAMPOO

Pramoxine HCl 1%,

Phytosphingosine Salicyloyl 0.05%

Soothing shampoo for dogs, cats and horses

16 fl oz (473 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 1 gallon (3.875 L)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7205-3

PHYTOVET P

ANTI-ITCH SHAMPOO

Pramoxine HCl 1%,

Phytosphingosine Salicyloyl 0.05%

Soothing shampoo for dogs, cats and horses

1 Gallon (3.785 L)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

PHYTOVET  P ANTI-ITCH
pramoxine hydrochloride, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7205
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: 11695-7205-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7205-2	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7205-3	3785 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2017

Labeler - Henry Schein Animal Health (603750329)

Registrant - Ceva Sante Animale (261126049)