DOUXO S3 PYO- ophytrium, chlorhexidine 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

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

DESCRIPTION

ACTIVE INGREDIENT: Chlorhexidine Digluconate 3%, Ophytrium® 0.5%

INACTIVE INGREDIENTS: Water, cocamidopropyl hydroxysultaine, decyl glucoside, capryloyl glycine, panthenol, saccharide isomerate, niacinamide, coco+vanilla hypoallergenic fragrance, PEG-200 glyceryl stearate, phenoxyethanol, citric acid, sodium hydroxide.

SPL UNCLASSIFIED SECTION

PROPERTIES: Chlorhexidine provides antiseptic cleansing and 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 or cats with bacterial or yeast skin infections that are responsive to chlorhexidine. Antiseptic shampoo that cleanses 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. Wash hands after use. Use DOUXO® S3 PYO 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

D98410M
18-L1-v2

"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®
PYO
Chlorhexidine 3%
Ophytrium® 0.5%

Shampoo

Bacterial or yeast
skin infections

Antiseptic | Hydrating

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®
PYO
Chlorhexidine 3%
Ophytrium® 0.5%

Shampoo

Bacterial or yeast
skin infections

Antiseptic | Hydrating

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  PYO
ophytrium, chlorhexidine shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-154
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
CHLORHEXIDINE (UNII: R4KO0DY52L) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PEG-200 GLYCERYL STEARATE (UNII: Z8ROG2A0LZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-154-01	200 mL in 1 BOTTLE, PLASTIC
2	NDC: 13744-154-02	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)