Animal NDC 13744-125-01 Douxo Calm Mousse

Phytosphingosine

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-125-01
Proprietary Name Douxo Calm Mousse 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 Phytosphingosine 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.For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area, massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.Dosage:Under 11 lbs: 1 pump per 2 lbs12-88 lbs: 1 pump per 4 lbsOver 89 lbs: 1 pump per 6 lbsDosage can be doubled for long-haired breeds.Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.
Active Ingredient(s)
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • CAPRYL/CAPRAMIDOPROPYL BETAINE (231H3ZT9NE)
  • DIETHYLHEXYL CARBONATE (YCD50O0Z6L)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • DILAURYL CITRATE (5OYS3G306B)
  • GLYCERIN (PDC6A3C0OX)
  • OAT (Z6J799EAJK)
  • SHEA BUTTER (K49155WL9Y)
  • ARGANIA SPINOSA SEED (8H7X7XB54H)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • CERAMIDE 3 (4370DF050B)
  • CERAMIDE 6 II (F1X8L2B00J)
  • CERAMIDE 1 (5THT33P7X7)
  • CHOLESTEROL (97C5T2UQ7J)
  • SODIUM LAUROYL LACTYLATE (7243K85WFO)
  • CARBOMER 940 (4Q93RCW27E)
  • XANTHAN GUM (TTV12P4NEE)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • SACCHAROMYCES CEREVISIAE (978D8U419H)
  • HYDROGENATED POLYBUTENE (1300 MW) (7D1YQ9Y5EZ)
  • POLYOXYL 20 CETOSTEARYL ETHER (YRC528SWUY)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (EL9825H96J)
  • SODIUM CHLORIDE (451W47IQ8X)
  • WATER (059QF0KO0R)
  • CAPRYL/CAPRAMIDOPROPYL BETAINE (231H3ZT9NE)
  • DIETHYLHEXYL CARBONATE (YCD50O0Z6L)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • DILAURYL CITRATE (5OYS3G306B)
  • GLYCERIN (PDC6A3C0OX)
  • OAT (Z6J799EAJK)
  • SHEA BUTTER (K49155WL9Y)
  • ARGANIA SPINOSA SEED (8H7X7XB54H)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • CERAMIDE 3 (4370DF050B)
  • CERAMIDE 6 II (F1X8L2B00J)
  • CERAMIDE 1 (5THT33P7X7)
  • CHOLESTEROL (97C5T2UQ7J)
  • SODIUM LAUROYL LACTYLATE (7243K85WFO)
  • CARBOMER 940 (4Q93RCW27E)
  • XANTHAN GUM (TTV12P4NEE)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • SACCHAROMYCES CEREVISIAE (978D8U419H)
  • HYDROGENATED POLYBUTENE (1300 MW) (7D1YQ9Y5EZ)
  • POLYOXYL 20 CETOSTEARYL ETHER (YRC528SWUY)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (EL9825H96J)
  • SODIUM CHLORIDE (451W47IQ8X)
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 Mousse Images

Douxo Calm Mousse 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 Mousse

ACTIVE INGREDIENTS: Phytosphingosine HCL 0.05%.

INACTIVE INGREDIENTS: Water, Capryl/Capramidopropyl Betaine, Diethylhexyl Carbonate, Polyglyceryl-4 Laurate, Phenoxyethanol, Dilauryl Citrate, Glycerin, Spent Grain Wax, Butyrospermum Parkii (Shea Butter) Extract, Argania Spinosa Kernal Oil,  Avena Sativa (Oat) Kernel Extract, Potassium Sorbate, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Butylene Glycol, Saccharomyces Cerevisiae Extract, Hydrogenated Polyisobutene, Ceteareth-20, Phenoxyethanol, Polyquaternium 51, Fragrance, 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.

For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area, massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.

For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

12-88 lbs: 1 pump per 4 lbs

Over 89 lbs: 1 pump per 6 lbs

Dosage can be doubled for long-haired breeds.

Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.


Warnings And Precautions



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

®2015 Ceva Animal Health, LLC


Principal Display Panel - 200 Ml (6.8 Ounce) Bottle



DOUXO®

Calm Mousse

Phytosphingosine HCL 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.