PHYTOVET P CREME- pramoxine hydrochloride, phytosphingosine salicyloyl rinse

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 CRÉME RINSE

Active Ingredients: pramoxine HCl 1%, phytosphingosine salicyloyl 0.05%,

Inactive Ingredients: water, cetearyl alcohol, PEG-40 hydrogenated castor oil, stearalkonium chloride, polysorbate-60, glycerin, dimethicone, fragrance, hydrolyzed oat protein, hydrolyzed wheat protein, methylchloroisothiazolinone, methylisothiazolinone.

Properties: PhytoVet P Créme Rinse is a pleasantly scented formulation designed for the temporary relief of itching in dogs, cats and horses. It contains pramoxine, a mild numbing agent, as well as colloidal oatmeal to further soothe irritated skin. PhytoVet P Créme Rinse 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: Shake well before use. After bathing with shampoo, apply PhytoVet P Creme Rinse onto the wet hair and massage thoroughly into the coat. Leave it on for 10 minutes, then rinse with cool water. May be used as part of a management plan  as recommended by your veterinarian.

WARNINGS AND PRECAUTIONS

Cautions: For external use on dogs, cats and horses only. Avoid contact with the eyes. In the 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: 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: 11695-7206-1

PHYTOVET P CRÉME RINSE

Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%

Soothing conditioner for dogs, cats and horses

8 fl oz (237 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

PHYTOVET  P CREME
pramoxine hydrochloride, phytosphingosine salicyloyl rinse

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7206
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) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
OATMEAL (UNII: 8PI54V663Y)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7206-1	237 mL in 1 BOTTLE, PLASTIC

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)