Label: KETO-C-TRIS WIPES- ketoconazole cloth

  • NDC Code(s): 86069-116-10
  • 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 November 21, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients: Ketoconazole 0.1%.

  • PURPOSE

    anti-fungal

  • INDICATIONS & USAGE

    Keto-C® Tris Wipes is an antiseptic (anti-fungal) solution for gentle cleansing of ears and skin. Contains Ketoconazole for the management of fungal activity. Can be used on dogs and cats.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, SD Alcohol-40B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine Technical Grade.

  • DOSAGE & ADMINISTRATION

    Instructions: Gently rub accessible portion of ear with wipe. Repeat with another clean pad until pad is free of debris. Use daily to maintain healthy clean ears. Safe for dogs and cats over 12 weeks of age. For topical use only within the ears.

  • STORAGE AND HANDLING

    Storage: Store at controlled room temperature.

  • PRECAUTIONS

    Cautions: For topical use in animals only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • SPL UNCLASSIFIED SECTION

    ANTISEPTIC & NON-IRRITATING

    FOR DOGS & CATS

    CUCUMBER MELON SCENT

    Stratford Animal Care
    A MEMBER OF THE SWEDENCARE FAMILY

    Distributed by: StratfordCare USA
    Odessa, FL 33556. 877-498-2002
    www.stratfordrx.com

  • Packaging

    Keto-C-116

  • INGREDIENTS AND APPEARANCE
    KETO-C-TRIS WIPES 
    ketoconazole cloth
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86069-116-10100 in 1 CONTAINER
    10.1 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/24/2021
    Labeler - Stratford Care Usa, Inc. (036650469)
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