DOUXO S3 SEB- 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

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.

DESCRIPTION

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 betain, punica granatum extract, saccharide isomerate, panthenol, niacinamide, coco + vanilla hypoallergenic fragrance, glycol distearate, phenoxyethanol, guar hydroxypropyltrimonium chloride, 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

VETERINARY INDICATIONS

INDICATIONS: For use on dogs & 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.

DOSAGE & ADMINISTRATION

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.

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.

WARNINGS

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. All trademarks are owned by
Ceva Santé Animale S.A. or its affiliates.
*Based on a survey of 400 veterinarians.

D98610P
18-L1-v2

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

DOUXO S3®
SEB
Ophytrium® 0.5%

WITH
OPHYTRIUM
FROM
S3
SAFE SKINCARE SELECTION ®

Shampoo

Oily to
flaky skin

Odor control | Seboregulating

For use on dogs & cats

DOUXO® is the
#1
topical brand
recommended
by VETERINARIANS*

6.7 fl oz (200 mL)

ceva

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DOUXO S3®
SEB
Ophytrium® 0.5%

WITH
OPHYTRIUM
FROM
S3
SAFE SKINCARE SELECTION ®

Shampoo

Oily to
flaky skin

Odor control | Seboregulating

For use on dogs & cats

DOUXO® is the
#1
topical brand
recommended
by VETERINARIANS*

16.9 fl oz (500 mL)

ceva

INGREDIENTS AND APPEARANCE

DOUXO S3  SEB
ophytrium shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-156
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	5.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRAMIDOPROPYL BETAINE (UNII: IQ93EE887Z)
CAPRYLAMIDOPROPYL BETAINE (UNII: 26JA650O77)
POMEGRANATE 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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-156-01	200 mL in 1 BOTTLE, PLASTIC
2	NDC: 13744-156-02	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)