Label: KETOWELL- chlorhexidine gluconate, ketoconazole shampoo

  • NDC Code(s): 86090-004-08, 86090-004-16
  • Packager: Pet MD Brands, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated September 7, 2023

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  • Active Ingredients:

    Chlorhexidine Gluconate 2% and Ketoconazole 1%.

  • INDICATIONS & USAGE

    KetoWELL Shampoo is a pleasantly scented cleansing shampoo. The shampoo may be used on dogs, cats, and horses. Good health begins with VetWELL.

  • Inactive Ingredients:

    Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

  • Directions for Use:

    Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow shampoo to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. Do not allow animal to lick or ingest product before rinsing. May be used initially 2 to 3 times a week for 4 weeks, then reduced to once a week, or as directed by your veterinarian.

  • Precautions:

    Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Not for otic use. Wash hands after using. Consult your vet before combining with other Chlorhexidine products.

  • Cautions:

    If undue skin irritation develops or increases, discontinue use and consult a veterinarian. KEEP OUT OF THE REACH OF CHILDREN.

  • Storage:

    Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    Formulated for Dogs, Cats, & Horses

    Cucumber-Melon Scent

    Manufactured for:
    VetWELL®
    Odessa, FL 33556
    www.vetwell.com

    MFG IN USA

  • Packaging

    KetoWellShampoo-004

  • INGREDIENTS AND APPEARANCE
    KETOWELL 
    chlorhexidine gluconate, ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86090-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86090-004-08237 mL in 1 BOTTLE, PLASTIC
    2NDC:86090-004-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/21/2018
    Labeler - Pet MD Brands, LLC (060164988)
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