Label: DOUXO CALM gel

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 20, 2015

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  • DESCRIPTION

    DOUXO®

    Calm Gel

    Phytosphingosine salicyloyl 0.20%

    ACTIVE INGREDIENTS: Phytosphingosine salicyloyl 0.20%

    INGREDIENTS: Water, Biosaccharide Gum-4, Butylene Glycol, PEG-8, Glycerin, Paraffinum Liquidum, Rubus Idaeus (Raspberry) Seed Oil,  Isostearyl Alcohol, Butylene Glycol Cocoate, Ethylcellulose, Cyclopentasiloxane, Dimethicone, Tocopherol, Sodium Dihydroacetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 80, Sodium Hydroxide, Phenoxyethanol, Hinokitiol, Nordihydroguaiaretic Acid.

  • INDICATIONS & USAGE

    INDICATIONS: For use on dogs and cats only. For the management of skin inflammation.

    DIRECTIONS FOR USE: Shake well before use. Spray directly on the skin by holding the pump approximately 8 inches from the skin. Apply once a day or as directed by your veterinarian.

  • PRECAUTIONS

    CAUTIONS: For external use in dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult your veterinarian.

  • WARNINGS

    WARNING: Keep out of the reach of children.

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    Authorized for sale through licensed veterinarians only.

    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 - 60 mL (2 OUNCE) Bottle

    DOUXO®

    Calm Gel

    Phytosphingosine salicyloyl 0.20%

    Allergies

    60 mL (2 fl. oz.)

    CEVA

    60 mL bottle label

  • INGREDIENTS AND APPEARANCE
    DOUXO CALM 
    douxo calm gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    COCONUT OIL GLYCERETH-8 ESTERS (UNII: 9V234MGT7F)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HINOKITIOL (UNII: 5MPS47D679)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13744-101-0160 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2015
    Labeler - Ceva Sante Animale (261126049)
    Registrant - Ceva Sante Animale (261126049)
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