DOUXO S3 SEB- ophytrium shampoo 
Ceva Sante Animale

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.

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DOUXO S3™ SEB

OPHYTRIUM 0.5%

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

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

ACTIVE INGREDIENT: Ophytrium 0.5%

INACTIVE INGREDIENTS: Water, cocomidopropyl hydroxysultaine, glycerine, sodium methyl lauroyl isethionate, sodium methyl cocoyl taurate, disodium laureth sulfosuccinate, caprylamidopropyl betaine/capramidopropyl betaine, seboliance™ (punica granatum extract),
pentavitin® (saccharide isomerate), panthenol, niacinamide (vit. PP), coco + vanilla hypoallergenic fragrance, glycol distearate, phenoxyethanol, guar gum, sodium benzoate, butylene glycol, acrylates/C10-30 alkyl acrylate, disodium EDTA, citric acid, sodium hydroxide.

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: For use on dogs or cats with oily or flaky skin. Helps control dandruff and odor by normalizing sebum production while hydrating the skin. Detangles the fur and leaves the coat soft and shiny.

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. 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 SEB Mousse for a leave-on solution.

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.

Store at room temperature.

“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™

SEB

OPHYTRIUM 0.5%

odor-control seboregulating

OILY TO FLAKEY SKIN

shampoo

For use on dogs or cats

6.7 fl oz (200 mL)

200 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 500 mL Bottle

DOUXO S3™

SEB

OPHYTRIUM 0.5%

odor-control seboregulating

OILY TO FLAKY SKIN

shampoo

For use on dogs or cats

16.9 fl oz (500 mL)

500 mL Bottle Label

DOUXO S3  SEB
ophytrium shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ) (OPHIOPOGON JAPONICUS ROOT - UNII:90PS6JV9GZ) OPHIOPOGON JAPONICUS ROOT5.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRAMIDOPROPYL BETAINE (UNII: IQ93EE887Z)  
CAPRYLAMIDOPROPYL BETAINE (UNII: 26JA650O77)  
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GUAR GUM (UNII: E89I1637KE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13744-156-01200 mL in 1 BOTTLE, PLASTIC
2NDC:13744-156-02500 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)

Revised: 11/2020
Document Id: 31a9362d-16e3-4302-9ab9-4d86a89a53ae
Set id: a8ebbdb1-acc3-4551-860a-4539cebede9e
Version: 1
Effective Time: 20201124
 
Ceva Sante Animale