DOUXO S3 CALM- ophytrium shampoo

DOUXO S3 by

Drug Labeling and Warnings

DOUXO S3 by is a Animal medication manufactured, distributed, or labeled by Ceva Sante Animale, TriRx Huntsville Pharmaceutical Services, LLC, SOCIETE INDUSTRIELLE LIMOUSINE D'APPLICATION BIOLOGIQUE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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.

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

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)

INGREDIENTS AND APPEARANCE

DOUXO S3  CALM
ophytrium shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-151
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
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GUAR GUM (UNII: E89I1637KE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-151-01	200 mL in 1 BOTTLE, PLASTIC
2	NDC: 13744-151-02	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)

Establishment
Name	Address	ID/FEI	Business Operations
TriRx Huntsville Pharmaceutical Services, LLC		117090286	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
SOCIETE INDUSTRIELLE LIMOUSINE D'APPLICATION BIOLOGIQUE		492816616	api manufacture