Label: KETOMAX FLUSH- chloroxylenol and ketoconazole solution

  • NDC Code(s): 68898-115-08
  • Packager: Animal Pharmaceuticals
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 11, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients  Purpose

    Ketoconazole, USP …….    .3% (w/w) ………  Antifungal

    Chloroxylenol, USP …….    .3% (w/w) ……… Antibacterial



  • PURPOSE

    Uses a medicated cleansing solution with broad spectrum antimicrobial and antifungal activity for dogs,
    cats and horses.


  • 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

    • use only on dogs, cats and horses
    • use topically only
    • 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
    Apply by squeezing bottle onto affected areas.
    Use once daily or as recommended by your veterinarian.


  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Alpha-Tocopherol Acetate, Bean, Benzyl Alcohol, Butylparaben, Edetate Disodium, Ethylparaben, Glycerin, Glyceryl Linoleate, Glyceryl Linolenate, Isobutylparaben, Methylparaben, Octoxynol 9, Phenoxyethanol, Propylene Glycol, Propylparaben, Sodium Ascorbyl Phosphate, Sodium Borate, Sorbitol, Vitamin A Palmitate, Water, Xanthan Gum


  • STORAGE AND HANDLING

    Other Information

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



    MANUFACTURED FOR
    Animal Pharmaceuticals
    www.anmpharm.com
    REV 0812
    Item No. 1101509

    PEEL HERE
    Ketomax FLUSH
    anmPHARM
    Veterinary
    CHART TAB
    RE-ORDER No. 078770926

    SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS


  • PRINCIPAL DISPLAY PANEL

    anmPHARM
    Ketomax pH 8.5 FLUSH
    A Ready-To-Use Innovative Broad-spectrum, Anti-microbial and Anti-fungal Cleansing Solution. Formulated with Sodium Borate Decahydrate to provide a Consistent Alkaline pH Of 8.5 in a Water-based and Non-Irritating Delivery System.

    Formulated for Dogs, Cats and Horses

    8 OZ (237 mL)

    PEEL HERE
    Ketomax FLUSH
    anmPHARM
    BRING THIS LABEL BACK TO YOUR VET FOR A REFILL
    8OZ REFILL REMINDER

    image descriptionKetomax8

  • INGREDIENTS AND APPEARANCE
    KETOMAX  FLUSH
    chloroxylenol and ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-115
    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:68898-115-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/04/2012
    Labeler - Animal Pharmaceuticals (166472444)