Label: ANTIBACTERIAL ANTIFUNGAL MEDICATED- chlorhexidine gluconate, ketoconazole shampoo

  • NDC Code(s): 86175-002-16, 86175-002-32
  • Packager: Alpha Paw Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 30, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

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

  • PURPOSE

    ANTIBACTERIAL & ANTIFUNGAL MEDICATED SHAMPOO For Dogs & Cats

  • DITCH THE ITCH!

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

  • INACTIVE INGREDIENTS

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

  • 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.

  • DIRECTIONS

    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. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

  • 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 473mL

    Package 473mL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL ANTIFUNGAL MEDICATED 
    chlorhexidine gluconate, ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86175-002
    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)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    Colororange (pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86175-002-16473 mL in 1 BOTTLE, PLASTIC
    2NDC:86175-002-321 in 1 PACKAGE
    2473 mL in 1 BOTTLE, PLASTIC; Number of Units = 2
    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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