DOUXO MICELLAR: Product Information

DOUXO MICELLAR- salicyloyl phytosphingosine solution
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.

DOUXO®

Micellar Solution

Phytosphingosine Salicyloyl 0.05%

ACTIVE INGREDIENT: Phytosphingosine Salicyloyl 0.05%

INGREDIENTS: Water, Polysorbate 80, SD Alcohol 40-B, Propylene Glycol, Laureth-9, Poloxamer 184, Imidazolidinyl Urea, Phenoxyethanol, Potassium Sorbate, Biosaccharide Gum-2, Citric acid, Fragrance.

PROPERTIES: Douxo® Micellar Solution contains micellar technology and soothing agents help emulsify and wash out waxy debris without drying the skin. The solution is non-greasy and non-staining. Douxo® Micellar Solution also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS: For use in dogs and cats for cleaning of the ear canal, eye contours and skin folds. May be used go clean soiled and matted hair, or greasy skin.

DIRECTIONS FOR USE: Shake well before use. For ear cleaning, ask your veterinarian which of the following protocols is best for your pet:

1) Moisten a cotton ball with solution and place in the entrance of the ear canal; OR

2) Hold the ear flap upwards and fill the ear canal with solution.

Then gently massage the base of the ear for 60 seconds. Remove the cotton ball (if used) and allow the pet to shake its head. Gently wipe away visible debris and excess solution with a clean, dry cotton ball.

To clean other areas of the skin, moisten absorbent material with solution and gently wipe the area to cleanse and remove debris. Repeat as necessary until clean.

CAUTIONS: For external use only; avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult with your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use in the case of a suspected ruptured eardrum.

WARNING: Keep out of the reach of children.

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 Ι 1-800-999-0297 I www.DOUXO.com

Douxo® is a registered trademark of Ceva Santé Animale S.A.

PRINCIPAL DISPLAY PANEL — 125 mL BOTTLE

DOUXO®

Micellar Solution

Phytosphingosine Salicyloyl 0.05%

Care

Phytosphingosine

125 ml (4.2 fl. oz.)

CEVA

PRINCIPAL DISPLAY PANEL — 250 mL BOTTLE

DOUXO®

Micellar Solution

Phytosphingosine Salicyloyl 0.05%

Care

Phytosphingosine

250 ml (8.4 fl. oz.)

CEVA

DOUXO MICELLAR phytosphingosine salicyloyl solution

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-158 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLOYL PHYTOSPHINGOSINE (PHYTOSPHINGOSINE) SALICYLOYL PHYTOSPHINGOSINE .5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL POLYSORBATE 80 PROPYLENE GLYCOL LAURETH-9 PHOSPHATE POLOXAMER 184 BIOSACCHARIDE GUM-2 IMIDUREA PHENOXYETHANOL POTASSIUM SORBATE CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:13744-158-01 125 mL in 1 BOTTLE, PLASTIC None 2 NDC:13744-158-02 250 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/05/2021

Labeler — Ceva Sante Animale (261126049)

Registrant — Ceva Sante Animale (261126049)

Revised: 03/2021 Ceva Sante Animale