Label: SEBOZOLE DEEP CLEANING, ANTIMICROBIAL- miconazole nitrate, salicylic acid, and chloroxylenol shampoo

  • NDC Code(s): 17030-013-08, 17030-013-10, 17030-013-16
  • Packager: Vetoquinol USA, Inc.
  • 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 December 10, 2020

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  • VETERINARY INDICATIONS

    Vetoquinol Sebozole™ Shampoo is uniquely formulated to provide antimicrobial, antifungal and antiseborrheic agents for optimal therapeutic effectiveness.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Miconazole Nitrate 2%, Salicylic Acid 2%, Chloroxylenol 1%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, Sodium C14-16 Olefin Sulfonate, Propylene Glycol, PEG 150 Pentaerythrityl Tetrastearate, Lauramide DEA, Sodium Thiosulfate, Sodium Hydroxide, Acrylates/C10-30 Alkylate Crosspolymer, Fragrance, FD&C Blue #1, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow #5.

  • INDICATIONS & USAGE

    INDICATIONS FOR USE: For dermatological conditions associated with infections responsive to Miconazole Nitrate, Salicylic Acid and Chloroxylenol.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Shake well. With tepid water, thoroughly wet animal's coat. Apply and lather shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Repeat twice weekly until symptoms subside, then weekly, or as directed by veterinarian.

  • PRECAUTIONS

    CAUTION: For topical use only on dogs, cats and horses. Avoid contact with eyes. Keep out of reach of children. Store at room temperature. If irritation develops, discontinue and consult your veterinarian.

    KEEP OUT OF REACH OF CHILDREN AND PETS.

    FOR ANIMAL USE ONLY.

  • SPL UNCLASSIFIED SECTION

    Distributed by Vetoquinol USA Inc.
    Ft. Worth, TX (USA) 76137
    www.vetoquinolusa.com
    1 (800) 267-5707

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 17030-013-16

    vetoquinoL

    SEBOZOLE™
    SHAMPOO

    Deep Cleaning, Antimicrobial

    2% Miconazole Nitrate, 2% Salicylic Acid, 1% Chloroxylenol.
    Antimicrobial, Antifungal and Antiseborrheic for Dermatological
    Conditions Responsive to Miconazole Nitrate, Salicylic Acid and
    Chloroxylenol.

    ANTIFUNGAL
    YEAST/
    BACTERIA
    DRY/FLAKY

    NET CONTENTS: 16 fl oz (473mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SEBOZOLE   DEEP CLEANING, ANTIMICROBIAL
    miconazole nitrate, salicylic acid, and chloroxylenol shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    PEG-150 Pentaerythrityl Tetrastearate (UNII: 8L4OOQ76AM)  
    Lauric Diethanolamide (UNII: I29I2VHG38)  
    SODIUM THIOSULFATE ANHYDROUS (UNII: L0IYT1O31N)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Thiosulfate (UNII: HX1032V43M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17030-013-16473 mL in 1 BOTTLE, PLASTIC
    2NDC:17030-013-08237 mL in 1 BOTTLE, PLASTIC
    3NDC:17030-013-103790 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/08/2020
    Labeler - Vetoquinol USA, Inc. (106824209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Hanpu Pharmaceutical CO. LTD654030428API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Hebei Jingy Medical Technology545119575API MANUFACTURE
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