Label: DOUXO CALM- douxo calm micro-emulsion spray spray

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 21, 2019

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  • 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.

  • SPL UNCLASSIFIED SECTION

    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

    200 mL Spray Bottle Label Front

    200 mL Spray Bottle Label Back

  • INGREDIENTS AND APPEARANCE
    DOUXO CALM 
    douxo calm micro-emulsion spray spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    QUATERNIUM-82 (UNII: AFS70NB1WJ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13744-124-01200 mL in 1 BOTTLE, SPRAY
    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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