Animal NDC 13744-104-01 Douxo Micellar

Phytosphingosine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-104-01
Proprietary Name Douxo Micellar 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 Ceva Sante Animale
Product Type Otc Animal Drug
Usage Information
    INDICATIONS: For use in dogs and cats only. For the cleaning of the ear canal, eye contours and skin folds. May be used go 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 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. 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 visible 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 visible debris.  Repeat as often as necessary until clean.
Active Ingredient(s)
  • Phytosphingosine Hydrochloride
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.

Douxo Micellar 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



DOUXO®

Micellar Solution

Phytosphingosine HCL 0.02%

ACTIVE INGREDIENT: Phytosphingosine HCL 0.02%

INGREDIENTS: Water, Polysorbate 80, Alcohol Denatured, Propylene Glycol, Laureth-9, Poloxamer 184, Biosaccharide Gum-2, Imidazolidinyl Urea,  Phenoxyethanol, Potassium Sorbate, Citric acid, Fragrance.

PROPERTIES: Douxo® Micellar Solution contains micellar technology and soothing agents help emulsify and wash out waxy debris without drying. The solution is non-greasy and non-staining. Douxo® Micellar Solution also contains Phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier.


Indications & Usage



INDICATIONS: For use in dogs and cats only. For the cleaning of the ear canal, eye contours and skin folds. May be used go 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 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.

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 visible 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 visible debris.  Repeat as often as necessary until clean.


Warnings And Precautions



CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult 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.

WARNING: Keep out of the reach of children.


Storage And Handling



STORAGE CONDITIONS: Store at room temperature. Do not freeze.

Available for sale through licensed veterinarians.


Other



Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 Ι 1-800-999-0297

Douxo® is a registered trademark of Ceva Santé Animale S.A.


Principal Display Panel - 125 Ml Bottle



DOUXO®

Micellar Solution

Phytosphingosine HCL 0.02%

Care

Phytosphingosine

125 ml (4.2 fl. oz.)

CEVA


Principal Display Panel - 250 Ml Bottle



DOUXO®

Micellar Solution

Phytosphingosine HCL 0.02%

Care

Phytosphingosine

250 ml (8.4 fl. oz.)

CEVA


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