DOUXO CHLORHEXIDINE- chlorhexidine, phytosphingosine spray

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

Micro-emulsion Spray

ACTIVE INGREDIENTS: Chlorhexidine gluconate 3% Phytosphingosine salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Hexyl Laurate, Glycerin, Cetearyl Alcohol, Ceteareth-20, Ceteareth-12, Glyceryl Stearate, PCA Ethyl Cocoyl Arginate, Potassium Sorbate, Sodium Hydroxide.

INDICATIONS & USAGE

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

DIRECTIONS FOR USE: Brush the hair coat against the natural fur line, then spray the product by holding the pump approx. 12 inches from the pet's body, thus dispensing the product over the targeted area. The product will disperse naturally. Do not over apply.

Dosage: 1 spray per 10 lbs. of bodyweight.

Dosage may be doubled for long-haired breeds.

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

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 irritation occurs or increases, discontinue use and consult with your veterinarian.

WARNING: Keep out of the reach of children.

SPL UNCLASSIFIED SECTION

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

Micro-emulsion Spray

Chlorhexidine gluconate 3%

Phytosphingosine salicloyl 0.05%

Antiseptic

Phytosphingosine

200 mL (6.8 fl. oz.)

Ceva

INGREDIENTS AND APPEARANCE

DOUXO CHLORHEXIDINE 
chlorhexidine, phytosphingosine spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-120
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
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	SALICYLOYL PHYTOSPHINGOSINE	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETEARETH-12 (UNII: 7V4MR24V5P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PYRROLIDONE CARBOXYLIC ACID ETHYL COCOYL ARGINATE (UNII: A53122S09O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-120-01	200 mL in 1 BOTTLE, SPRAY

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)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Tinci Materials Technology Co., Ltd.		530146380	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Evonik Nutrition & Care GmbH		314906476	api manufacture