Label: DOUXO S3 CALM MOUSSE- ophytrium liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 24, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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.

  • 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.

    Directions graphic

  • 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.

  • SPL UNCLASSIFIED SECTION

    “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.

  • 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)

    150 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    DOUXO S3  CALM MOUSSE
    ophytrium liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ) (OPHIOPOGON JAPONICUS ROOT - UNII:90PS6JV9GZ) OPHIOPOGON JAPONICUS ROOT7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GUAR GUM (UNII: E89I1637KE)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13744-150-01150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/25/2020
    Labeler - Ceva Sante Animale (261126049)
    Registrant - Ceva Sante Animale (261126049)