Animal NDC 11695-7239-4 Phyto Micellar Otic Cleanser
Phytosphingosine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-7239-4
Proprietary Name Phyto 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 Hydrochloride 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 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; or2)      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.
Active Ingredient(s)
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • SEC-LAURETH-9 (441JX1IO3Z)
  • 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)
  • SEC-LAURETH-9 (441JX1IO3Z)
  • 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.

Phyto 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



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 & Usage



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.


Warnings And Precautions



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 And Handling



Storage conditions: Store at room temperature. Do not freeze.


Other



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)


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)


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