Label: ANTIBACTERIAL ANTIFUNGAL MEDICATED- 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 March 15, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Chlorhexidine Gluconate...............................2%
    Ketoconazole..................................................1%

  • PURPOSE

    ANTIBACTERIAL & ANTIFUNGAL MEDICATED SPRAY For Dogs & Cats

  • DITCH THE ITCH!

    Kiss itch and irritation goodbye for your scratchy pets. Treatment is as easy as point, spray and soothe. Skin conditions that are responsive to Ketoconazole and Chlorhexidine stand no chance against this powerful spray formula. Vitamin E and essential fatty acids follow close behind to ensure that treated skin is nourished.

  • INACTIVE INGREDIENTS

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

  • 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. If undue skin irritation develops or increases, discontinue use and consult a veterinarian

  • DIRECTIONS

    Spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian. Do not allow animal to lick the treated areas until
    dry to prevent ingestion.

  • CAUTIONS

    If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

  • STORAGE

    Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    Contains chlorhexidine & ketoconazole
    Freshens & deodorizes
    Treatment for dry, itchy irritated skin
    Removes yeast, bacteria, fungus & ringworm

    GENTLE ON SKIN
    CHOSEN BY TOP VETS
    FOR DOGS AND CATS

    ALPHA PAW
    Questions or Comments:
    Call (800) 363-5458
    www.alphapaw.com
    Alpha Paw LLC, Las Vegas NV 89139

  • Packaging

    Package 237mL

    Package 237mL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL ANTIFUNGAL MEDICATED 
    chlorhexidine gluconate, ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86175-003
    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:86175-003-16237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/03/2022
    Labeler - Alpha Paw Inc (117036685)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropichem Research Labs, LLC dba Vetio603123068manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Garonit Pharmaceutical, Inc800875106api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilab Chemicals and Pharmaceuticals Private Limited915893696api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Pharmaceuticals Limited916130698api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Piramal Pharma Limited919067108api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Sharon Bio-Medicine Limited675472749api manufacture
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