Animal NDC 13744-123-01 Douxo
Douxo Calm

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-123-01
Proprietary Name Douxo 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 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 pruritis and inflammation associated with allergic conditions.DIRECTIONS FOR USE: Wet the animal with warm water and apply DOUXO® Calm Shampoo. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed. Shampoo 2 to 3 times per week, for 1 to 2 weeks, or as directed 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)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • SODIUM LAURETH SULFATE (BPV390UAP0)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • PEG-7 GLYCERYL COCOATE (VNX7251543)
  • ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (EPA1872R1N)
  • COCO GLUCOSIDE (ICS790225B)
  • COCONUT ALCOHOL (13F4MW8Y9K)
  • BARLEY (5PWM7YLI7R)
  • SHEA BUTTER (K49155WL9Y)
  • ARGAN OIL (4V59G5UW9X)
  • CYCLOMETHICONE 4 (CZ227117JE)
  • OAT (Z6J799EAJK)
  • GLYCERIN (PDC6A3C0OX)
  • 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)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POLYQUATERNIUM-10 (400 CPS AT 2%) (HB1401PQFS)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • SACCHAROMYCES CEREVISIAE (978D8U419H)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (EL9825H96J)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • SODIUM HYDROXIDE (55X04QC32I)
  • WATER (059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • SODIUM LAURETH SULFATE (BPV390UAP0)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • PEG-7 GLYCERYL COCOATE (VNX7251543)
  • ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (EPA1872R1N)
  • COCO GLUCOSIDE (ICS790225B)
  • COCONUT ALCOHOL (13F4MW8Y9K)
  • BARLEY (5PWM7YLI7R)
  • SHEA BUTTER (K49155WL9Y)
  • ARGAN OIL (4V59G5UW9X)
  • CYCLOMETHICONE 4 (CZ227117JE)
  • OAT (Z6J799EAJK)
  • GLYCERIN (PDC6A3C0OX)
  • 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)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POLYQUATERNIUM-10 (400 CPS AT 2%) (HB1401PQFS)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • SACCHAROMYCES CEREVISIAE (978D8U419H)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (EL9825H96J)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • 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 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 Shampoo

ACTIVE INGREDIENT: Phytosphingosine HCL 0.05%.

INACTIVE INGREDIENTS: Water, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Decyl Glucoside, Polyoxyethylene (PEG-7) Glyceryl Monococoate, Acrylates/Steareth-20 Methacrylate Copolymer, Cocoglucoside, Coconut Alcohol, Spent Grain Wax, Butyrospermum Parkii (Shea Butter) Extract, Argania Spinosa Kernel Oil, Cyclopentasiloxane, Avena Sativa (Oat) Kernel Extract, Glycerin, Potassium Sorbate, Ceramide 3, Ceramide 6 II, Ceramide 1, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Phenoxyethanol, Polyquaternium-10, Butylene Glycol, Saccharomyces Cerevisiae Extract, Polyquaternium-51, Methylisothiazolinone, Sodium Hydroxide.

PROPERTIES: DOUXO® Calm Shampoo is a formulation designed to support sensitive and allergic skin in dogs and cats. It is soap-free, and contains highly purified fraction of oatmeal, plant extracts and lipids to help soothe irritations, moisturize and help restore the skin lipid content. DOUXO®Calm Shampoo also contains Phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier.


Indications & Usage



INDICATIONS: For use on dogs and cats only. For the management of pruritis and inflammation associated with allergic conditions.

DIRECTIONS FOR USE: Wet the animal with warm water and apply DOUXO® Calm Shampoo. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed.

Shampoo 2 to 3 times per week, for 1 to 2 weeks, or as directed 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. 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 Sogeval S.A.

®2015 Ceva Animal Health, LLC


Principal Display Panel - 200 Ml (6.8 Ounce) Bottle



DOUXO®

Calm Shampoo

Phytosphingosine HCl 0.05%

Allergies

Phytosphingosine

200 ml (6.8 fl. oz.)

Ceva


Principal Display Panel - 500 Ml (16.9 Ounce) Bottle



DOUXO®

Calm Shampoo

Phytosphingosine HCL 0.05%

Allergies

Phytosphingosine

500 ml (16.9 fl. oz.)

Ceva


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