DOUXO MICELLAR- phytosphingosine hydrochloride solution

DOUXO MICELLAR by

Drug Labeling and Warnings

DOUXO MICELLAR by is a Animal medication manufactured, distributed, or labeled by Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

DOUXO®

Micellar Solution

Phytosphingosine HCL 0.02%

ACTIVE INGREDIENT: Phytosphingosine HCL 0.02%

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

PROPERTIES: Douxo® Micellar Solution is a formulation designed for the cleansing of ears in dogs and cats. The micellar technology and soothing agents help emulsify and wash out waxy debris without drying. The solution is non-greasy and non-staining. Douxo® Micellar Solution also contains Phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

INDICATIONS: For use in dogs and cats only. For the cleaning of the ear canal. May be used for the cleansing of the eye contour or soiled and matted hairs. May be used for the cleansing of skin folds or the local cleaning of greasy skin associated with seborrheic conditions.

DIRECTIONS FOR USE:

Ear use: instill a few drops into the ear canal while keeping the ear flap up. Gently massage the base of the ear for a few seconds. Wipe the interior flap with cotton or gauze.

Skin cleaning: apply on the targeted area with cotton or gauze.

Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be part of a management plan as recommended  by your veterinarian.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult 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 AND HANDLING

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

Availabl for sale through licensed veterinarians only.

SPL UNCLASSIFIED SECTION

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 Ι 1-800-999-0297

Douxo® is a registered trademark of Sogeval S.A.

©2015 Ceva Animal Health, LLC

PRINCIPAL DISPLAY PANEL - 125 mL BOTTLE

DOUXO®

Micellar Solution

Phytosphingosine HCL 0.02%

Maintenance

Phytosphingosine

125 ml (4.2 fl. oz.)

CEVA

PRINCIPAL DISPLAY PANEL - 250 mL BOTTLE

DOUXO®

Micellar Solution

Phytosphingosine HCL 0.02%

Maintenance

Phytosphingosine

250 ml (8.4 fl. oz.)

CEVA

INGREDIENTS AND APPEARANCE

DOUXO MICELLAR 
phytosphingosine hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURETH-9 (UNII: 0AWH8BFG9A)
POLOXAMER 184 (UNII: BIS92ZSF57)
BIOSACCHARIDE GUM-2 (UNII: UVQ34I5XKQ)
IMIDUREA (UNII: M629807ATL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-104-01	125 mL in 1 BOTTLE, PLASTIC
2	NDC: 13744-104-02	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2015

Labeler - Ceva Sante Animale (261126049)

Registrant - Ceva Sante Animale (261126049)