Label: KETO-C XL WIPES- ketoconazole, chlorhexidine gluconate cloth

  • NDC Code(s): 86069-113-70
  • Packager: Stratford Care Usa, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 2, 2021

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

  • INDICATIONS & USAGE

    Keto-C​® XL Wipes ​contains an antiseptic (antibacterial and antifungal) solution for the topical management of skin conditions that are responsive to chlorhexidine and ketoconazole. Keto-C® XL Wipes can be used for the antiseptic cleansing for face folds, finger folds, as well as underarms and groin areas.

  • DOSAGE & ADMINISTRATION

    ​Directions for Use: ​Thoroughly wipe affected area with a pad 1 to 3 times per day, or as directed by your veterinarian. Do not allow the animal to lick the treated areas until dry to prevent ingestion. Wipes should be used for one application only; do not reuse. Avoid use on open wounds, cuts, or raw areas (use Keto-C®​ Flush instead).

  • PRECAUTIONS

    ​Precautions:​ Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

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

  • STORAGE AND HANDLING

    ​Storage:​ Store at room temperature. Protect from freezing.

  • INACTIVE INGREDIENT

    Ingredients:​ Propylene Glycol, Purified Water, Peg-5 Cocamide, Polyethylene Glycol 600, Benzyl Alcohol, Octyl Phenol Ethylene, Fragrance

  • SPL UNCLASSIFIED SECTION

    ​For Dogs & Cats​

    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

    KetoC1

  • INGREDIENTS AND APPEARANCE
    KETO-C XL WIPES 
    ketoconazole, chlorhexidine gluconate cloth
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PEG-5 COCAMINE (UNII: ZA36V5XS8F)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    4-N-OCTYLPHENOL (UNII: 7DF2B8LH3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86069-113-7070 in 1 BOTTLE
    11 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2020
    Labeler - Stratford Care Usa, Inc. (036650469)
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