Label: GNC PETS ANTI-BACETERIAL AND ANTI-FUNGAL (PREMIUM FORMULA)- chlorhexidine gluconate and ketoconazole shampoo

  • NDC Code(s): 43655-004-01, 43655-004-02
  • Packager: General Nutrition Corporation
  • 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 November 5, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    342004
    IMG

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  • Directions for use:

    Using warm water, wet coat thoroughly. Apply shampoo from base of neck to the tail, paying special attention to avoid eyes. Gently massage deep into coat and skin. Allow shampoo to remain on pet for up to 5 minutes for maximum benefit. Rinse well. Repeat as needed.

    For external use only. Safe for dogs 12 weeks of age and older. In case of eye contact flush thoroughly with water. If condition persists more than 7 days, consult your veterinarian.

    Keep out of reach of children and pets. Do not use more frequently than once a week.

    For maximum relief, follow with GNC Pets Anti-Bacterial & Anti-Fungal Medicated Conditioner to speed the relief of symptoms.

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  • Active Ingredients:

    Chlorhexidine Gluconate 1.00%
    Ketoconazole 0.25%
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  • SPL UNCLASSIFIED SECTION

    Other Ingredients: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide DEA, Polyacrylate-1 Crosspolymer, Glycerin, Chlorohexidine Gluconate, Tocopheryl Acetate, Ketoconazole, Retinyl Palmitate, Ascorbic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Lactate, Lactic Acid, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40, Ext. Violet 2.

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  • SPL UNCLASSIFIED SECTION

    For more information: 1-888-612-1198

    SHOP NOW @ PETSMART.COM

    Distributed by:
    General Nutrition Corporation
    Pittsburgh, PA 15222

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  • PRINCIPAL DISPLAY PANEL - 503 ml Bottle Label

    MEDICATED +
    ANTI-BACTERIAL
    & ANTI-FUNGAL
    SHAMPOO

    PREMIUM FORMULA

    GNC
    PETS

    S
    MEDICATED
    SHAMPOO

    Helps relieve bacterial skin
    infections related to allergies,
    grooming and scratching

    Provides relief from itching
    due to fungal infections

    LAVENDER SCENT
    NET WT. 17 OZ (503 ML)

    • MEDICATED CARE •

    PRINCIPAL DISPLAY PANEL - 503 ml Bottle Label
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  • INGREDIENTS AND APPEARANCE
    GNC PETS ANTI-BACETERIAL AND ANTI-FUNGAL (PREMIUM FORMULA) 
    chlorhexidine gluconate and ketoconazole shampoo
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:43655-004
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate 10 mg  in 1 mL
    Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Coco Diethanolamide (UNII: 92005F972D)  
    Glycerin (UNII: PDC6A3C0OX)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43655-004-01 503 mL in 1 BOTTLE, PLASTIC
    2 NDC:43655-004-02 946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 02/06/2012
    Labeler - General Nutrition Corporation (014960165)
    Establishment
    Name Address ID/FEI Business Operations
    Marianna Industries, Inc 045570736 MANUFACTURE, API MANUFACTURE
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