DOUXO S3 SEB MOUSSE- ophytrium liquid

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, phenoxyethanol, sodium lauroyl sarcosinate, punica granatum extract, saccharide isomerate, panthenol, hydrolyzed oats, coco+vanilla hypoallergenic fragrance, butylene glycol, PEG-40 hydrogenated castor oil, 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 oily to 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: Apply to a brushed, dry coat. First, gently massage onto the problem area until the mousse reaches the skin. Repeat this action all over the body, avoiding the eyes and mouth. Let air dry. Brush for a shiny coat. Wash hands after use. Use DOUXO® S3 SEB Shampoo to clean the skin if needed.

	1 pump per 2 lbs		1 pump per 4 lbs	Double the dosage for long and/or thick fur.
Cat or dog ≤13 lbs		Dog >13 lbs
Use every 2-3 days for 3 weeks. Contains approx. 200 pumps.

PRECAUTIONS

CAUTION: 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

D98510P 18-S1-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 - 150 mL Bottle Label

DOUXO S3®
SEB
Ophytrium® 0.5%

WITH
OPHYTRIUM
FROM
S3
SAFE SKINCARE SELECTION
®

Mousse

Oily to
flaky skin

Odor control | Seboregulating

For use on dogs & cats

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

5 fl oz (150 mL)

Ceva

INGREDIENTS AND APPEARANCE

DOUXO S3  SEB MOUSSE
ophytrium liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-155
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
OAT (UNII: Z6J799EAJK)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-155-01	150 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)