Label: DOUXO- douxo calm solution

  • NDC Code(s): 13744-123-01, 13744-123-02
  • Packager: Ceva Sante Animale
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated July 26, 2019

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  • 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.

  • SPL UNCLASSIFIED SECTION

    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

    200 mL Bottle label front

    200 mL Bottle Label BACK

  • 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

    500 mL Label

    500 mL Labelk BACK

  • INGREDIENTS AND APPEARANCE
    DOUXO 
    douxo calm solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    BARLEY (UNII: 5PWM7YLI7R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    OAT (UNII: Z6J799EAJK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13744-123-01200 mL in 1 BOTTLE, PLASTIC
    2NDC:13744-123-02500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2016
    Labeler - Ceva Sante Animale (261126049)
    Registrant - Ceva Sante Animale (261126049)
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