DOUXO CALM- douxo calm micro-emulsion spray spray 
Ceva Sante Animale

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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: 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.

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 CONDITIONS: Store at room temperature. Do not freeze.

Authorized for sale through licensed veterinarians only.

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

200 mL Spray Bottle Label Front

200 mL Spray Bottle Label Back

DOUXO CALM 
douxo calm micro-emulsion spray spray
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
RASPBERRY SEED OIL (UNII: 9S8867952A)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
QUATERNIUM-82 (UNII: AFS70NB1WJ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13744-124-01200 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2016
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 8/2019
Document Id: 44591a81-da73-45c8-a3f6-cc385160046e
Set id: 9ed90b4d-72cc-45fa-904a-c43209b8a2ab
Version: 2
Effective Time: 20190821
 
Ceva Sante Animale