Animal NDC 13744-151-02 Douxo S3 Calm
Ophytrium

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-151-02
Proprietary Name Douxo S3 Calm 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 and hydrate the skin. Detangles the fur and leaves the coat soft and shiny.DIRECTIONS FOR USE: Use one pump for every 4 lbs. Double the dosage for long and/or thick fur. Wet with cool water from the neck down. First, gently massage shampoo onto the problem area. Repeat on entire body and leave on for 5-10 minutes before rinsing. Repeat if necessary. Use DOUXO® S3 CALM Mousse for a leave-on solution.
Active Ingredient(s)
  • Ophiopogon Japonicus Root
Inactive Ingredient(s)
  • POTASSIUM HYDROLYZED JOJOBA ESTERS (CH428W5O62)
  • GLYCOL DISTEARATE (13W7MDN21W)
  • SACCHARIDE ISOMERATE (W8K377W98I)
  • NIACINAMIDE (25X51I8RD4)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • GUAR GUM (E89I1637KE)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (59TL3WG5CO)
  • EDETATE DISODIUM (7FLD91C86K)
  • SODIUM BENZOATE (OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • SODIUM HYDROXIDE (55X04QC32I)
  • POTASSIUM HYDROLYZED JOJOBA ESTERS (CH428W5O62)
  • GLYCOL DISTEARATE (13W7MDN21W)
  • SACCHARIDE ISOMERATE (W8K377W98I)
  • NIACINAMIDE (25X51I8RD4)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • GUAR GUM (E89I1637KE)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (59TL3WG5CO)
  • EDETATE DISODIUM (7FLD91C86K)
  • SODIUM BENZOATE (OJ245FE5EU)
  • 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 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

OPHYTRIUM 0.75%

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

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, cocamidopropyl hydroxysultaine, sodium methyl lauroyl isethionate, sodium methyl cocoyl taurate, disodium laureth sulfosuccinate, sodium cocoamphoacetate, panthenol, jojoba esters, glycol distearate, pentavitin® (saccharide isomerate),
niacinamide (Vit. PP), coco+vanilla hypoallergenic fragrance, phenoxyethanol, guar gum, acrylates/C10-30 alkyl acrylate, disodium EDTA, sodium benzoate, 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 and hydrate the skin. Detangles the fur and leaves the coat soft and shiny.

DIRECTIONS FOR USE: Use one pump for every 4 lbs. Double the dosage for long and/or thick fur. Wet with cool water from the neck down. First, gently massage shampoo onto the problem area. Repeat on entire body and leave on for 5-10 minutes before rinsing. Repeat if necessary. Use DOUXO® S3 CALM Mousse for a leave-on solution.


Precautions



CAUTIONS: 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

shampoo

For use on dogs or cats

6.7 fl oz (200 mL)


Principal Display Panel - 500 Ml Bottle



DOUXO S3™

CALM

OPHYTRIUM 0.75%

soothing

ITCHY, IRRITATED SKIN

shampoo

For use on dogs or cats

16.9 fl oz (500 mL)


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