DOUXO S3 CARE- ophytrium shampoo

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™ Care

OPHYTRIUM 0.25%

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

High tolerance formula. Hypoallergenic fragrance, adjusted pH. Formulated and tested by veterinary dermatology experts.

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Ophytrium 0.25%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, cocamidopropyl hydroxysultaine, sodium methyl lauroyl isethionate, sodium methyl cocoyl taurate, disodium laureth sulfosuccinate, sodium cocoamphoacetate, glycol distearate, panthenol, pentavitin® (saccharide isomerate), niacinamide (Vit. PP), jojoba esters, coco+vanilla hypoallergenic fragrance, phenoxyethanol, guar gum, acrylates/C10-30 alkyl acrylate, sodium benzoate, disodium EDTA, 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 to clean and hydrate the skin. Detangles the fur and leaves the coat soft and shiny. Ultra-gentle and protecting for regular use, suitable for all fur types.

DIRECTIONS: Use one pump for every 4 lbs. Double the dosage for long and/or thick fur. Wet with cool water from the neck down. Apply, massage and leave-on for several minutes before rinsing. Repeat if necessary.

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.

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™

CARE

OPHYTRIUM 0.25%

ultra-gentle protecting

FOR REGULAR USE

shampoo

For use on dogs or cats

6.7 fl oz (200 mL)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle

DOUXO S3™

CARE

OPHYTRIUM 0.25%

ultra-gentle protecting

FOR REGULAR USE

shampoo

For use on dogs or cats

16.9 fl oz (500 mL)

INGREDIENTS AND APPEARANCE

DOUXO S3  CARE
ophytrium shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-152
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	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
NIACINAMIDE (UNII: 25X51I8RD4)
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GUAR GUM (UNII: E89I1637KE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-152-01	200 mL in 1 BOTTLE, PLASTIC
2	NDC: 13744-152-02	500 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)