DOUXO S3 CALM MOUSSE- ophytrium liquid

DOUXO S3 by

Drug Labeling and Warnings

DOUXO S3 by is a Animal medication manufactured, distributed, or labeled by Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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)

INGREDIENTS AND APPEARANCE

DOUXO S3  CALM MOUSSE
ophytrium liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ) (OPHIOPOGON JAPONICUS ROOT - UNII:90PS6JV9GZ)	OPHIOPOGON JAPONICUS ROOT	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-150-01	150 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/25/2020

Labeler - Ceva Sante Animale (261126049)

Registrant - Ceva Sante Animale (261126049)