DOUXO CALM- douxo calm gel 
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 GEL

DOUXO®

Calm Gel

Phytosphingosine salicyloyl 0.20%

ACTIVE INGREDIENTS: Phytosphingosine salicyloyl 0.20%

INGREDIENTS: Water, Biosaccharide Gum-4, Butylene Glycol, PEG-8, Glycerin, Paraffinum Liquidum, Rubus Idaeus (Raspberry) Seed Oil,  Isostearyl Alcohol, Butylene Glycol Cocoate, Ethylcellulose, Cyclopentasiloxane, Dimethicone, Tocopherol, Sodium Dihydroacetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 80, Sodium Hydroxide, Phenoxyethanol, Hinokitiol, Nordihydroguaiaretic Acid.

INDICATIONS: For use on dogs and cats only. For the management of skin inflammation.

DIRECTIONS FOR USE: Shake well before use. Spray directly on the skin by holding the pump approximately 8 inches from the skin. Apply once a day or as directed by your veterinarian.

CAUTIONS: For external use in 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 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 Sogeval S.A.

©2015 Ceva Animal Health, LLC

PRINCIPAL DISPLAY PANEL - 60 mL (2 OUNCE) Bottle

DOUXO®

Calm Gel

Phytosphingosine salicyloyl 0.20%

Allergies

60 mL (2 fl. oz.)

CEVA

60 mL bottle label

DOUXO CALM 
douxo calm gel
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
COCONUT OIL GLYCERETH-8 ESTERS (UNII: 9V234MGT7F)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HINOKITIOL (UNII: 5MPS47D679)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13744-101-0160 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/01/2015
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 10/2015
Document Id: f64ca5f0-dffd-4375-a28a-60077a42193b
Set id: 4d42a4c3-5e54-4341-8495-185f9154ec5f
Version: 1
Effective Time: 20151020
 
Ceva Sante Animale