PHYTOVET by Henry Schein Animal Health / Ceva Sante Animale

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]

PHYTOVET P ANTI-ITCH- pramoxine hydrochloride, phytosphingosine salicyloyl spray 
Henry Schein Animal Health

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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PHYTOVET P ANTI-ITCH SPRAY

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

Inactive Ingredients: water, glycerin, silicone emulsion, stearamidopropyl dimethylamine lactate, PEG-75 lanolin, sodium lactate, hydrolyzed oat protein, methylisothiazolinone.

Properties: PhytoVet P Anti-Itch Spray is a solution designed for the temporary relief of itching in dogs, cats and horses. It is alcohol free and contains colloidal oatmeal and moisturizers to further soothe irritation. PhytoVet P Anti-Itch Spray also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

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. Spray directly onto the target area. If needed, ruffle or part the hair to allow direct contact with the skin. Massage well. Do not allow the animal to lick the treated area until dry. Apply once a day for 2 to 3 weeks or as recommended by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.

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: Store at room temperature. Do not freeze.

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: 11695-7203-1

PHYTOVET P ANTI-ITCH SPRAY

Pramoxine HCl 1%,

Phytosphingosine Salicyloyl 0.05%

Soothing spray for dogs, cats and horses

8 fl oz (237 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PHYTOVET  P ANTI-ITCH
pramoxine hydrochloride, phytosphingosine salicyloyl spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7203
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)
GLYCERIN (UNII: PDC6A3C0OX)
STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)
PEG-75 LANOLIN (UNII: 09179OX7TB)
SODIUM LACTATE (UNII: TU7HW0W0QT)
OATMEAL (UNII: 8PI54V663Y)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7203-1	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2017	03/25/2020

Labeler - Henry Schein Animal Health (603750329)

Registrant - Ceva Sante Animale (261126049)

Revised: 3/2020

Document Id: 13f0a664-5dad-47e9-9cde-002fde82bbf2

50577-6

Set id: 0939043a-a2d0-48c0-b301-35d84e5a34c3

Version: 2

Effective Time: 20200325

 

Henry Schein Animal Health