Label: CERASOOTHE CHX PLUS KET- chlorhexidine gluconate, ketoconazole shampoo

  • NDC Code(s): 11695-6973-1, 11695-6973-2, 11695-6973-3
  • Packager: BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
  • 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 April 12, 2022

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

  • DESCRIPTION

    CeraSoothe CHX+KET

    Antiseptic Shampoo

    Fragrance: Cucumber melon

    Formulated for cats, dogs and horses

    Keep out of reach of children

    For animal use only

    A shampoo with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic skin cleansing. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin’s natural immune system and provide building blocks for renewed skin barrier integrity.

    Active ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%.

    Inactive ingredients: Water, lauramine oxide, cocamidopropyl betaine, polyacrylate-1 crosspolymer, decyl glucoside, glycolic acid, avena sativa (oat) kernel extract, glycerin, ceramide EOP, ceramide EOS, ceramide NP, potassium sorbate, fragrance, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

  • INDICATIONS & USAGE

    Indications: For use on cats, dogs, and horses with bacterial or fungal skin infections that are responsive to chlorhexidine gluconate and ketoconazole.

    Directions for use: Bathe 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, use CeraSoothe CHX+KET antiseptic mousse, wipes, and/or spray.

  • WARNINGS AND PRECAUTIONS

    Cautions: For use on cats, dogs and horses only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult your veterinarian.

  • STORAGE AND HANDLING

    Storage: Store at room temperature. Do not freeze.

  • SPL UNCLASSIFIED SECTION

    QUESTIONS?

    (855) 724-3461

    Distributed by:

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

  • PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

    Inspired by veterinarians

    CeraSoothe CHX+KET

    Antiseptic Shampoo

    Fragrance: Cucumber melon

    Chlorhexidine gluconate 2%

    Ketoconazole 1%

    Formulated for cats, dogs and horses

    Keep out of reach of children

    For animal use only

    NDC: 11695-6973-1

    Net contents: 8 fl oz (237 mL)

    8 ounce bottle label

  • PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

    Inspired by veterinarians

    CeraSoothe CHX+KET

    Antiseptic Shampoo

    Fragrance: Cucumber melon

    Chlorhexidine gluconate 2%

    Ketoconazole 1%

    Formulated for cats, dogs and horses

    Keep out of reach of children

    For animal use only

    NDC: 11695-6973-2

    Net contents: 16 fl oz (473 mL)

    16 ounce bottle label

  • PRINCIPAL DISPLAY PANEL - 1 Gallon (3.785L) Jug

    Inspired by veterinarians

    CeraSoothe CHX+KET

    Antiseptic Shampoo

    Fragrance: Cucumber melon

    Chlorhexidine gluconate 2%

    Ketoconazole 1%

    Formulated for cats, dogs and horses

    Keep out of reach of children

    For animal use only

    NDC: 11695-6973-3

    Net contents: 1 gallon (3.785L)

    1 gallon jug label

  • INGREDIENTS AND APPEARANCE
    CERASOOTHE  CHX PLUS KET
    chlorhexidine gluconate, ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6973
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    AVENANTHRAMIDES (UNII: 5PA41O4AIT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-6973-1237 mL in 1 BOTTLE, PLASTIC
    2NDC:11695-6973-2473 mL in 1 BOTTLE, PLASTIC
    3NDC:11695-6973-33785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/09/2021
    Labeler - BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA (603750329)
    Registrant - Ceva Sante Animale (261126049)