MICELLAR OTIC CLEANSER- phytosphingosine salicyloyl solution

MICELLAR by

Drug Labeling and Warnings

MICELLAR by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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 & USAGE

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.

WARNINGS AND PRECAUTIONS

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 AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

MICELLAR  OTIC CLEANSER
phytosphingosine salicyloyl solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6988
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	SALICYLOYL PHYTOSPHINGOSINE	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6988-1	125 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6988-2	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/16/2021

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)