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

  • NDC Code(s): 11695-6975-1
  • 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 May 2, 2022

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

  • DESCRIPTION

    CeraSoothe CHX+KET

    Antiseptic Topical Spray

    Fragrance: Cucumber melon

    A leave-on spray with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic activity on the skin. 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, glycerin, polysorbate 20, propylene glycol, lactic acid, avena sativa (oat) kernal extract, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, methylisothiazolinone.

  • INDICATIONS & USAGE

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

    Directions for use: Apply 1 to 3 times per day for 2-3 weeks or as directed by your veterinarian. Part the fur and spray directly on the affected area of the skin. Gently smooth product on the skin to ensure full coverage. Wash hands after use.  Do not allow the animal to lick the treated area.

  • WARNINGS AND PRECAUTIONS

    Cautions: For external 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 with 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 Topical Spray

    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: 11695-6975-1

    Net Contents: 8 fl oz (237 mL)

    covetrus

    8 ounce bottle label

  • INGREDIENTS AND APPEARANCE
    CERASOOTHE  CHX PLUS KET
    chlorhexidine gluconate, ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6975
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    AVENANTHRAMIDES (UNII: 5PA41O4AIT)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-6975-1237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/16/2021
    Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
    Registrant - Ceva Sante Animale (261126049)