Label: PHARMASEB- chloroxylenol and ketoconazole shampoo

  • NDC Code(s): 68898-101-01, 68898-101-08, 68898-101-16
  • 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 Ingredients Purpose

    Ketoconazole, USP ........... 1% (w/w) ........... Antifungal

    Chloroxylenol, USP ........... 2% (w/w) ........... Antibacterial




  • PURPOSE

    Uses a medicated shampoo with broad spectrum antimicrobial and antifungal activity designed for dogs, cats, and horses w/dermatological conditions responsive to chloroxylenol and ketoconazole.


  • DOSAGE & ADMINISTRATION

    Directions

    Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage medicated shampoo into the wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water.

  • PRINCIPAL DISPLAY PANEL

    PhrmsebSham0812

  • INGREDIENTS AND APPEARANCE
    PHARMASEB 
    chloroxylenol and ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL20 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-101-08237 mL in 1 BOTTLE, PLASTIC
    2NDC:68898-101-16474 mL in 1 BOTTLE, PLASTIC
    3NDC:68898-101-013785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2010
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Custom Veterinary Services, Inc. (619511483)
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

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Clinical Trials, PubMed, Biochemical Data Summary

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