DOUXO CALM- douxo calm serum gel

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 Serum

Phytosphingosine salicyloyl 0.2%

ACTIVE INGREDIENT: Phytosphingosine salicyloyl 0.2%

INACTIVE INGREDIENTS: Water, biosaccharide gum-4, butylene glycol, PEG-8, glycerin, paraffinum liquidum, rubus idaeus (raspberry) seed oil, cyclopentasiloxane, isostearyl alcohol, butylene glycol cocoate, phenoxyethanol, tocopheryl acetate, dimethicone, sodium dehydroacetate, acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate-80, ethylcellulose, hinokitiol, sodium hydroxide, nordihydroguaiaretic acid.

INDICATIONS & USAGE

INDICATIONS: For itching and inflammation associated with allergic conditions in dogs and cats. 

DIRECTIONS FOR USE: Shake well before use.  Apply once a day or as directed by your veterinarian.  Hold the bottle approximately 8 inches from the skin.  Depress spray nozzle to apply 2-3 sprays, which treats an area about 4 inches in diameter.

PRECAUTIONS

CAUTIONS: For external use on dogs or cats only.  Avoid contact with eyes.  If eye contact occurs, rinse thoroughly and consult your veterinarian.  If skin irritation occurs or increases, discontinue use and consult with your veterinarian. 

WARNING: Keep out of reach of children

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at room temperature.  Do not freeze.

SPL UNCLASSIFIED SECTION

Manufactured for: Ceva Animal Health, LLC, Lenexa, KS 66215

1-800-999-0297, www.douxo.com

DOUXO® is a registered trademark of Ceva Santé Animale S.A.

PRINCIPAL DISPLAY PANEL - 60 mL (2 OUNCE) Bottle

DOUXO®

Calm Serum

Phytosphingosine salicyloyl 0.2%

For Use on Dogs and Cats

Allergies

2 fl. oz. (60 mL)

Ceva

INGREDIENTS AND APPEARANCE

DOUXO CALM 
douxo calm serum gel

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13744-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
MASOPROCOL (UNII: 7BO8G1BYQU)
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-160-01	60 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/30/2019

Labeler - Ceva Sante Animale (261126049)

Registrant - Ceva Sante Animale (261126049)