DOUXO CHLORHEXIDINE- chlorhexidine, climbazole, phytosphingosine solution

DOUXO CHLORHEXIDINE by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

DOUXO®

Chlorhexidine Shampoo

ACTIVE INGREDIENTS: Chlorhexidine gluconate 3%, Climbazole 0.5%, Phytosphingosine salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Capryloyl Glycine, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Triethanolamine, Phenoxyethanol, Sodium Hydroxide, Fragrance, Citric Acid.

PROPERTIES: DOUXO® Chlorhexidine Shampoo is a formulation designed for the antiseptic cleansing of the skin of dogs and cats. It is soap-free and contains mild cleansing bases and moisturizers. DOUXO® Chlorhexidine Shampoo also contains Phytosphingosine, a Ceva exclusive pro-ceramide to help soothe skin irritations and support a healthy skin barrier.

INDICATIONS & USAGE

INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and climbazole.

DIRECTIONS FOR USE: Wet the animal with warm water and apply DOUXO® Chlorhexidine Shampoo. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed. Shampoo 2 to 3 times per week, for 1 to 2 weeks, or as directed by your veterinarian. May be used as 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.

WARNING: Keep out of the reach of children.

STORAGE AND HANDLING

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

Authorized for sale through licensed veterinarians only.

SPL UNCLASSIFIED SECTION

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 ¦ 1-800-999-0297

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

®2015 Ceva Animal Health, LLC

PRINCIPAL DISPLAY PANEL - 200 mL (6.8 OUNCE) Bottle

DOUXO®

Chlorhexidine Shampoo

Chlorhexidine gluconate 3%, Climbazole 0.5%, 

Phytosphingosine salicloyl 0.05%

Antiseptic 

Phytosphingosine

200 mL (6.8 fl. oz.)

Ceva

PRINCIPAL DISPLAY PANEL - 500 mL (16.9 OUNCE) Bottle

DOUXO®

Chlorhexidine Shampoo

Chlorhexidine gluconate 3%, Climbazole 0.5%,

Phytosphingosine salicloyl 0.05%

Antiseptic

Phytosphingosine

500 mL (16.9 fl. oz.)

Ceva

INGREDIENTS AND APPEARANCE

DOUXO CHLORHEXIDINE 
chlorhexidine, climbazole, phytosphingosine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	30 mg  in 1 mL
CLIMBAZOLE (UNII: 9N42CW7I54) (CLIMBAZOLE - UNII:9N42CW7I54)	CLIMBAZOLE	5 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	SALICYLOYL PHYTOSPHINGOSINE	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-119-01	200 mL in 1 BOTTLE, PLASTIC
2	NDC: 13744-119-02	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2016

Labeler - Ceva Sante Animale (261126049)

Registrant - Ceva Sante Animale (261126049)