DOUXO CALM- douxo calm micro-emulsion spray spray

DOUXO CALM by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

DOUXO®

Calm

Micro-emulsion Spray

ACTIVE INGREDIENTS: Phytosphingosine salicloyl 0.05%.

INACTIVE INGREDIENTS: Water, Hexyl Laurate, Glyceryl Stearate, Ceteareth-12, Cetearyl Alcohol, Glycerin, Rubus Idaeus (Rasberry) Seed Oil, Ceteareth-20, Quaternium-82, Dipropylene Glycol, Potassium Sorbate, Methylisothiazolinone, Hinokitiol, Sodium Hydroxide.

INDICATIONS & USAGE

INDICATIONS: For use on dogs and cats only. For the management of pruritus and inflammation associated with allergic conditions.

DIRECTIONS FOR USE: Shake well before use.  Brush the hair coat against the natural fur line.  Spray the product by holding the pump approx. 12 inches from the pet's body, thus dispending 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 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 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 Ceva Santé Animale S.A.

PRINCIPAL DISPLAY PANEL - 200 mL (6.8 OUNCE) Bottle

DOUXO®

Calm

Micro-emulsion Spray

Phytosphingosine salicloyl 0.05%

Allergies

Phytospingosine

200 mL (6.8 fl. oz.)

Ceva

INGREDIENTS AND APPEARANCE

DOUXO CALM 
douxo calm micro-emulsion spray spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
RASPBERRY SEED OIL (UNII: 9S8867952A)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
QUATERNIUM-82 (UNII: AFS70NB1WJ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-124-01	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)