DOUXO CHLORHEXIDINE PS CLIMBAZOLE MOUSSE- chlorhexidine, climbazole, phytosphingosine liquid

DOUXO CHLORHEXIDINE PS CLIMBAZOLE MOUSSE by

Drug Labeling and Warnings

DOUXO CHLORHEXIDINE PS CLIMBAZOLE MOUSSE 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 Mousse

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

INACTIVE INGREDIENTS: Water, Polysorbate 80, Propylene Glycol, Benzyl Alcohol, Laureth-23, Poloxamer 184, Fragrance.

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: Shake well before use.

For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area, massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.

For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

12-88 lbs: 1 pump per 4 lbs

Over 89 lbs: 1 pump per 6 lbs

Dosage can be doubled for long-haired breeds.

Apply every 3 days for 2 to 3 weeks or as recommended 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. If contact with the eyes occurs, rinse thoroughly and consult your veterinarian. If irritation occurs or increases, discontinue use and consult 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 BOTTLE LABEL

DOUXO®

Chlorhexidine Mousse

Chlorhexidien gluconate 3%

Climbazole 0.5%

Phytosphingosine salicloyl 0.05%

Antispetic

Phytospingosine

200 ml (6.8 fl. oz)

Ceva

INGREDIENTS AND APPEARANCE

DOUXO CHLORHEXIDINE PS CLIMBAZOLE MOUSSE 
chlorhexidine, climbazole, phytosphingosine liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-122
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	0.5 mg  in 1 mL
CLIMBAZOLE (UNII: 9N42CW7I54) (CLIMBAZOLE - UNII:9N42CW7I54)	CLIMBAZOLE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-122-01	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)