Label: KETOWELL- chlorhexidine gluconate, ketoconazole spray

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

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Drug Label Information

Updated September 7, 2023

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  • Active Ingredients:

    Chlorhexidine Gluconate 2% and Ketoconazole 1%

  • INDICATIONS & USAGE

    KetoWELL topical spray is formulated with fatty acids and Vitamin E moisturize and hydrate skin. For dogs, cats, and horses. Alcohol-free formula. Good health begins with VetWELL.

  • Inactive Ingredients:

    Water, Glycerin, Propylene Glycol, Polysorbate 20, Lactic Acid, PEG-75 Lanolin, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Fragrance, Methylisothiazolinone.

  • Directions for Use:

    Spray directly onto affected area(s) up to 3 times daily. Do not allow the animal to lick the area(s) until dry to prevent ingestion.

  • Precautions:

    For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. 

  • Cautions:

    If undue skin irritation develops or increases, discontinue use and consult a veterinarian. KEEP OUT OF THE REACH OF CHILDREN. Consult your vet before combining with other Chlorhexidine products.

  • Storage:

    Store at controlled room temperature. 

  • SPL UNCLASSIFIED SECTION

    Formulated for Dogs, Cats, & Horses

    ALCOHOL FREE

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

    MFG IN USA

  • Packaging

    008

  • INGREDIENTS AND APPEARANCE
    KETOWELL 
    chlorhexidine gluconate, ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86090-008
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    Colororange (Pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86090-008-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/31/2018
    Labeler - Pet MD Brands, LLC (060164988)
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