Label: PHARMASEB WIPES- chloroxylenol and ketoconazole solution

  • NDC Code(s): 68898-104-60
  • Packager: Animal Pharmaceuticals
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 11, 2021

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose

    Ketoconazole, USP ……. 0.3% (w/w) ………Antifungal

    Chloroxylenol, USP ……. 0.3% (w/w) ………Antibacterial

  • PURPOSE


    Uses a medicated wipe for dermatological conditions associated with infections responsive to Ketoconazole and Chloroxylenol USP on dogs, cats and horses. For localized treatment between generalized therapy.

  • WARNINGS AND PRECAUTIONS

    Warnings

    • For Animal Use Only
    • Consult your veterinarian before use

    Ask a veterinarian before use if your animal is using other medications.

    When Using this Product

    • for topical use only on dogs, cats and horses
    • avoid contact with eyes and mucous membranes

    Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.


  • DOSAGE & ADMINISTRATION

    Directions for use

    Treat affected areas 2-3 times daily, or as directed by your veterinarian. Gently wipe affected area throughly. Do not allow animal to lick treated area until dry to prevent ingestion. Each wipe should be used once and discarded.

  • STORAGE AND HANDLING

    Other Information

    • store at room temperature (59˚F – 86˚F)
    • store in a cool dry place.
  • PRINCIPAL DISPLAY PANEL

    PhrmSebWipe0812

  • INGREDIENTS AND APPEARANCE
    PHARMASEB  WIPES
    chloroxylenol and ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE3 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-104-6075 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2010
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Custom Veterinary Services, Inc. (619511483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services, Inc.619511483manufacture, api manufacture
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