FDA.reportPublic FDA data

DOUXO CALM

Manufacturer
Ceva Sante Animale
Effective date
2019-04-30
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:43:44

Label at a glance#

ProductDOUXO CALM
Active ingredientSALICYLOYL PHYTOSPHINGOSINE
Label structure6 sections

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOUXO®

Calm Serum

Phytosphingosine salicyloyl 0.2%

For Use on Dogs and Cats

Allergies

2 fl. oz. (60 mL)

Ceva

60 mL bottle label60 mL bottle label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13744-160-01DOUXO CALM60 mL in 1 BOTTLE, SPRAYGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13744-160DOUXO CALM (DOUXO CALM SERUM) GEL [CEVA SANTE ANIMALE]11 package rows20241031_b9a8490e-a07b-4a5d-80c4-74d453f889a1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13744-16013744-160-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLOYL PHYTOSPHINGOSINEU891J4JCNHACTIB
WATER059QF0KO0RIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-BUTYLENE GLYCOL MONOCOCOATEXK3264896JIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
RASPBERRY SEED OIL9S8867952AIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
SODIUM HINOKITIOL5MPS47D679IACT
MASOPROCOL7BO8G1BYQUIACT
ETHYLCELLULOSE7Z8S9VYZ4BIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.