Animal NDC 13744-124-01 Douxo Calm

Douxo Calm Micro-emulsion Spray

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-124-01
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 Micro-emulsion Spray 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 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.
Active Ingredient(s)
  • Salicyloyl Phytosphingosine
Inactive Ingredient(s)
  • RASPBERRY SEED OIL (9S8867952A)
  • POLYOXYL 20 CETOSTEARYL ETHER (YRC528SWUY)
  • QUATERNIUM-82 (AFS70NB1WJ)
  • SODIUM HYDROXIDE (55X04QC32I)
  • RASPBERRY SEED OIL (9S8867952A)
  • POLYOXYL 20 CETOSTEARYL ETHER (YRC528SWUY)
  • QUATERNIUM-82 (AFS70NB1WJ)
  • SODIUM HYDROXIDE (55X04QC32I)
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 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

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 & Usage



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.


Warnings And Precautions



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 And Handling



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

Authorized for sale through licensed veterinarians only.


Other



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


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