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Animal NDC 13744-160-01 Douxo Calm

Douxo Calm Serum

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-160-01
Proprietary Name Douxo Calm What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Douxo Calm Serum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Ceva Sante Animale
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Salicyloyl Phytosphingosine
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • BIOSACCHARIDE GUM-4 (9XRL057X90)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • 1,2-BUTYLENE GLYCOL MONOCOCOATE (XK3264896J)
  • PEG-8 DIMETHICONE (GIA7T764OD)
  • MINERAL OIL (T5L8T28FGP)
  • GLYCERIN (PDC6A3C0OX)
  • ISOSTEARYL ALCOHOL (Q613OCQ44Y)
  • RASPBERRY SEED OIL (9S8867952A)
  • CYCLOMETHICONE 5 (0THT5PCI0R)
  • DIMETHICONE (92RU3N3Y1O)
  • ALPHA-TOCOPHEROL ACETATE (9E8X80D2L0)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (8Z5ZAL5H3V)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • SODIUM HYDROXIDE (55X04QC32I)
  • SODIUM DEHYDROACETATE (8W46YN971G)
  • SODIUM HINOKITIOL (5MPS47D679)
  • MASOPROCOL (7BO8G1BYQU)
  • ETHYLCELLULOSE (7Z8S9VYZ4B)
  • WATER (059QF0KO0R)
  • BIOSACCHARIDE GUM-4 (9XRL057X90)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • 1,2-BUTYLENE GLYCOL MONOCOCOATE (XK3264896J)
  • PEG-8 DIMETHICONE (GIA7T764OD)
  • MINERAL OIL (T5L8T28FGP)
  • GLYCERIN (PDC6A3C0OX)
  • ISOSTEARYL ALCOHOL (Q613OCQ44Y)
  • RASPBERRY SEED OIL (9S8867952A)
  • CYCLOMETHICONE 5 (0THT5PCI0R)
  • DIMETHICONE (92RU3N3Y1O)
  • ALPHA-TOCOPHEROL ACETATE (9E8X80D2L0)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (8Z5ZAL5H3V)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • SODIUM HYDROXIDE (55X04QC32I)
  • SODIUM DEHYDROACETATE (8W46YN971G)
  • SODIUM HINOKITIOL (5MPS47D679)
  • MASOPROCOL (7BO8G1BYQU)
  • ETHYLCELLULOSE (7Z8S9VYZ4B)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Douxo Calm Images

Douxo Calm Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Other



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

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

DOUXO®Â ï»¿ï»¿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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.