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

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® 0.75%

INACTIVE INGREDIENTS: Water, cocamidopropyl hydroxysultaine, sodium methyl lauroyl isethionate, sodium methyl cocoyl taurate, disodium laureth sulfosuccinate, sodium cocoamphoacetate, panthenol, jojoba esters, glycol distearate, saccharide isomerate, niacinamide, coco+vanilla hypoallergenic fragrance, phenoxyethanol, guar hydroxypropyltrimonium chloride, acrylates/C10-30 alkyl acrylate, disodium EDTA, sodium benzoate, citric acid, sodium hydroxide.

SPL UNCLASSIFIED SECTION

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 itchy, irritated, or allergic skin. Helps soothe and hydrate 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 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.

D98110P
18-L1-v2

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.

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

DOUXO S3®
CALM
Ophytrium® 0.75%

Shampoo

Itchy, irritated
or allergic skin

Soothing

WITH
OPHYTRIUM
FROM
S3
SAFE SKINCARE SELECTION®

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®
CALM
Ophytrium® 0.75%

Shampoo

Itchy, irritated
or allergic skin

Soothing

WITH
OPHYTRIUM
FROM
S3
SAFE SKINCARE SELECTION®

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  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)