MICELLAR OTIC CLEANSER- phytosphingosine salicyloyl 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.

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MICELLAR OTIC CLEANSER

Micellar Otic Cleanser

Phytosphingosine Salicyloyl 0.05%

A non-greasy formula that cleans and deodorizes the ear canal.  Contains micellar technology to help emulsify and wash out waxy debris without drying the skin.  It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

Active Ingredient: Phytosphingosine Salicyloyl 0.05%

Inactive 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.

Indications: For use in cats, dogs, and horses to gently cleanse the ear canal or other areas of the skin. 

Directions for use: 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 upward and fill with solution.

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

Cautions: For external use on cats, dogs, and horses 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 with a suspected ruptured eardrum.

Storage: Store at room temperature. Do not freeze.

Reorder #073122

Questions? (855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

PRINCIPAL DISPLAY PANEL - 125 mL BOTTLE

Micellar

Otic Cleanser

Fragrance: Green tea

Phytosphingosine salicyloyl 0.05%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6988-1

Net contents: 4.2 fl oz (125mL)

covetrus
image description

PRINCIPAL DISPLAY PANEL - 250 mL BOTTLE

Micellar

Otic Cleanser

Fragrance: Green tea

Phytosphingosine salicyloyl 0.05%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6988-2

Net contents: 8.4 fl oz (250mL)

covetrus

image description

MICELLAR  OTIC CLEANSER
phytosphingosine salicyloyl solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6988
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAURETH-9 PHOSPHATE (UNII: 0N8G76HI1O)  
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:11695-6988-1125 mL in 1 BOTTLE, PLASTIC
2NDC:11695-6988-2250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/16/2021
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 5/2022
Document Id: 7f3a608e-dcca-4fc7-996e-1d18a043a754
Set id: 932a6c6b-db35-463c-a2a4-4718c4119b57
Version: 2
Effective Time: 20220523
 
Butler Animal Health Supply, LLC dba Covetrus North America