KETO-C (CHLORHEXIDINE GLUCONATE, KETOCONAZOLE) SPRAY [STRATFORD PHARMACEUTICALS]

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KETO-C (CHLORHEXIDINE GLUCONATE, KETOCONAZOLE) SPRAY [STRATFORD PHARMACEUTICALS]
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NDC 86069-103-08
Set ID d934aa76-4535-4b6a-ab4b-5b02aa9890f7
Category OTC ANIMAL DRUG LABEL
Packager Stratford Care Usa, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active Ingredients: Chlorhexidine Gluconate 2%, Ketoconazole 1%.

  • PURPOSE

    Antibacterial and antifungal

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

  • INDICATIONS & USAGE

    Keto-C™ Spray is an alcohol-free antiseptic (antibacterial and antifungal) formulation designed for dogs, cats and horses with dermatological
    conditions that are responsive to chlorhexidine and ketoconazole. It also contains Essential Fatty Acids and Vitamin E to nourish the skin and further control irritation.

  • DOSAGE & ADMINISTRATION

    Directions for Use: 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.

  • PRECAUTIONS

    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.

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

  • STORAGE AND HANDLING

    Storage: Store at controlled room temperature.

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    Formulated for Dogs, Cats & Horses

    FOR VETERINARY USE ONLY

    Available Through Licensed Veterinarians Only.

    Manufactured for:

    Stratford Care USA
    Odessa, FL 33556
    877-498-2002
    www.stratfordrx.com

    MADE IN THE USA

  • Packaging

    Keto10308

    Keto10304

  • INGREDIENTS AND APPEARANCE
    KETO-C 
    chlorhexidine gluconate, ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-103
    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:86069-103-08237 mL in 1 BOTTLE, PLASTIC
    2NDC:86069-103-04118 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/11/2011
    Labeler - Stratford Care Usa, Inc. (036650469)
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