PHYTO MICELLAR OTIC CLEANSER- phytosphingosine hydrochloride 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.

----------

Phyto micellar Otic Cleanser

Active ingredient: Phytosphingosine HCI 0.02%

Ingredients: Water, polysorbate-80, SD alcohol 40-B, propylene glycol, laureth-9, poloxamer 184, imidazolidinyl urea, phenoxyethanol, potassium sorbate, biosaccharide gum-2, citric acid, fragrance.

Properties: Phyto micellar otic cleansing solution contains micellar technology and soothing agents to help emulsify and wash out waxy debris without drying the skin. The solution is also non-greasy and non-staining. It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

Indications: For use in dogs and cats only. Ideal for cleaning the ear canal, eye contours, and skin folds. May also be used to clean soiled and matted hair, or greasy skin associated with seborrheic conditions.

Directions for use: Shake well before use. For ear cleaning, ask your veterinarian which of the two following protocols is best for your pet:

1)      Moisten a cotton ball with solution and place in the entrance of the ear canal; or

2)      Hold the ear flap upwards and fill the ear canal with solution.

Then gently massage the base of the ear for 60 seconds. Remove the cotton ball (if used) and allow the pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball.

To clean other areas of the skin, moisten a cotton ball or gauze with the solution and gently wipe the area to cleanse and remove debris. Repeat as necessary until clean.

Cautions: For external use in dogs and cats only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult with 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:

Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 125 mL BOTTLE

covetrus

NDC: 11695-7239-4

Phyto micellar

Phytosphingosine HCl 0.02%

Otic Cleansing Solution

For use on dogs and cats

For animal use only

Keep out of reach of children

Net contents: 4.2 fl oz (125 mL)

125 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 250 mL BOTTLE

covetrus

NDC: 11695-7239-8

Phyto micellar

Phytosphingosine HCl 0.02%

Otic Cleansing Solution

For use on dogs and cats

For animal use only

Keep out of reach of children

Net contents: 8.4 fl oz (250 mL)

250 mL Bottle Label

PHYTO  MICELLAR OTIC CLEANSER
phytosphingosine hydrochloride solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7239
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SEC-LAURETH-9 (UNII: 441JX1IO3Z)  
POLOXAMER 184 (UNII: BIS92ZSF57)  
BIOSACCHARIDE GUM-2 (UNII: UVQ34I5XKQ)  
IMIDUREA (UNII: M629807ATL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7239-4125 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7239-8250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 12/2019
Document Id: 897ef45e-5e10-44c0-b42f-3f9a7ffcd381
Set id: 51e168e6-0fd5-47de-a0b2-75358bca9057
Version: 1
Effective Time: 20191206
 
Butler Animal Health Supply, LLC dba Covetrus North America