PHYTOVET EAR CLEANSING- salicylic acid, phytosphingosine hcl solution

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 EAR CLEANSING SOLUTION

Active Ingredients: salicylic acid, 0.15%, phytosphingosine HCl 0.01%.

Inactive Ingredients: water, SDA 40B 190 proof, propylene glycol, disodium oleamido MIPA sulfosuccinate, nonoxynol-12, glycerin, fragrance, benzoic acid, benzyl alcohol, lactic acid, tetrasodium EDTA, sodium dioctyl sulfosuccinate, aloe barbadensis leaf juice.

Properties: PhytoVet Ear Cleansing Solution is specifically formulated to deodorize and gently clean, dry and acidify the ear canal. This provides an optimal environment to help maintain healthy ears. PhytoVet Ear Cleansing Solution also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

Indication: For use on dogs, cats and horses only. For cleansing and/or drying the ear canal.

Directions for Use: Apply liberally into the ear canal. Massage the base of the ear. Allow pet to shake head. Clean excess with a cotton ball. In excessively dirty ears, apply 2-3 times daily over several days. For maintenance of healthy ears, apply 1-2 times weekly or as directed by your veterinarian. Recommended after swimming to help dry ear canal.

WARNINGS AND 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. Do not use in the case of a suspected ruptured eardrum.

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 - 4 fl oz (118 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7212-1

PHYTOVET EAR

CLEANSING SOLUTION

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

For cleansing and/or drying the ear canal for use in dogs, cats and horses.

4 fl oz (118 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 8 fl oz (237 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-7212-2

PHYTOVET EAR

CLEANSING SOLUTION

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

For cleansing and/or drying the ear canal for use in 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: 11695-7212-3

PHYTOVET EAR

CLEANSING SOLUTION

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

For cleansing and/or drying the ear canal for use in dogs, cats and horses.

16 fl oz (473 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

PHYTOVET  EAR CLEANSING
salicylic acid, phytosphingosine hcl solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
NONOXYNOL-12 (UNII: 6NR43D77O6)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE SODIUM (UNII: MP1J8420LU)
DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7212-1	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7212-2	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7212-3	473 mL in 1 BOTTLE, PLASTIC

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

Labeler - Henry Schein Animal Health (603750329)

Registrant - Ceva Sante Animale (261126049)