Animal NDC 13744-150-01 Douxo S3 Calm Mousse
Ophytrium

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-150-01
Proprietary Name Douxo S3 Calm Mousse 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 Ophytrium 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 on dogs or cats with itchy, irritated or allergic skin. Helps soothe while hydrating the skin. Detangles the fur and leaves the coat soft and shiny.DIRECTIONS: Apply to a brushed, dry coat. First, gently massage onto the problem area until the mousse reaches the skin. Repeat this action all over the body, avoiding the eyes and mouth. Let air dry. Brush for a shiny coat. Wash hands after use. Use DOUXO® S3 CALM Shampoo to clean the skin if needed.
Active Ingredient(s)
  • Ophiopogon Japonicus Root
Inactive Ingredient(s)
  • SACCHARIDE ISOMERATE (W8K377W98I)
  • PANTHENOL (WV9CM0O67Z)
  • NIACINAMIDE (25X51I8RD4)
  • GUAR GUM (E89I1637KE)
  • PEG-40 CASTOR OIL (4ERD2076EF)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • SODIUM HYDROXIDE (55X04QC32I)
  • SACCHARIDE ISOMERATE (W8K377W98I)
  • PANTHENOL (WV9CM0O67Z)
  • NIACINAMIDE (25X51I8RD4)
  • GUAR GUM (E89I1637KE)
  • PEG-40 CASTOR OIL (4ERD2076EF)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • SODIUM HYDROXIDE (55X04QC32I)
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 S3 Calm Mousse 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



Other



DOUXO S3™ CALM

mousse

OPHYTRIUM 0.75%

Soap, sulfate, paraben, phthalate, colorant and nanoparticle FREE

Leave-on for longer lasting action. High tolerance formula. Hypoallergenic fragrance, adjusted pH. Formulated and tested by veterinary dermatology experts.

“How to use” video www.douxo.com

Manufactured for Ceva Animal Health, LLC, Lenexa, KS 66215, 800-999-0297
Pentavitin® is a registered trademark of DSMP Assets B.V.
All other trademarks are owned by Ceva Santé Animale S.A. or its affiliates.


Otc - Active Ingredient



ACTIVE INGREDIENT: Ophytrium 0.75%


Inactive Ingredient



INACTIVE INGREDIENTS: Water, capryl/capramidopropyl betaine, phenoxyethanol, pentavitin® (saccharide isomerate), panthenol, niacinamide (vit. PP), coco+vanilla hypoallergenic fragrance, guar gum, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide.


Description



PROPERTIES: Ophytrium is a purified, natural ingredient from the S3 - Safe Skincare Selection. Ophytrium has been carefully selected for its high tolerance and simultaneous threefold action on the skin’s ecosystem: • Helps support the skin's physical barrier for supple, hydrated skin • Helps support the microbial flora for healthy skin • Helps soothe irritated skin


Indications & Usage



INDICATIONS: For use on dogs or cats with itchy, irritated or allergic skin. Helps soothe while hydrating the skin. Detangles the fur and leaves the coat soft and shiny.

DIRECTIONS: Apply to a brushed, dry coat. First, gently massage onto the problem area until the mousse reaches the skin. Repeat this action all over the body, avoiding the eyes and mouth. Let air dry. Brush for a shiny coat. Wash hands after use. Use DOUXO® S3 CALM Shampoo to clean the skin if needed.


Precautions



CAUTION: For external use on dogs or cats only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Keep out of reach of children.


Storage And Handling



Store at room temperature.


Principal Display Panel - 200 Ml Bottle



DOUXO S3™

CALM

OPHYTRIUM 0.75%

soothing

ITCHY, IRRITATED SKIN

mousse

leave-on

For use on dogs or cats

5 fl oz (150 mL)


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