Animal NDC 11695-6988-2 Micellar Otic Cleanser

Phytosphingosine Salicyloyl

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-6988-2
Proprietary Name Micellar Otic Cleanser What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Phytosphingosine Salicyloyl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Butler Animal Health Supply, Llc Dba Covetrus North America
Product Type Otc Animal Drug
Usage Information
    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; OR2) 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.
Active Ingredient(s)
  • Salicyloyl Phytosphingosine
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • LAURETH-9 PHOSPHATE (0N8G76HI1O)
  • POLOXAMER 184 (BIS92ZSF57)
  • BIOSACCHARIDE GUM-2 (UVQ34I5XKQ)
  • IMIDUREA (M629807ATL)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • LAURETH-9 PHOSPHATE (0N8G76HI1O)
  • POLOXAMER 184 (BIS92ZSF57)
  • BIOSACCHARIDE GUM-2 (UVQ34I5XKQ)
  • IMIDUREA (M629807ATL)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Micellar Otic Cleanser Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Other



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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.