PHYTOVET EAR CLEANSING- salicylic acid, phytosphingosine hcl solution 
Butler Animal Health Supply, LLC dba Covetrus North America

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.

----------

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.

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.

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 Conditions: 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 - 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

4 ounce bottle label

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

8 ounce bottle label

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

16 ounce bottle label

PHYTOVET  EAR CLEANSING
salicylic acid, phytosphingosine hcl solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7212-1118 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7212-2237 mL in 1 BOTTLE, PLASTIC
3NDC:11695-7212-3473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/25/201708/13/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 8/2020
 
Butler Animal Health Supply, LLC dba Covetrus North America