Label: PHYTO CHX KET ANTISEPTIC- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl spray

  • NDC Code(s): 11695-7226-8
  • 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 November 15, 2019

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

  • DESCRIPTION

    Phyto CHX+KET Antiseptic Spray

    Active Ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.02%.

    Inactive Ingredients: Water, glycerin, PEG-75 lanolin, lactic acid, polysorbate 20, aloe barbadenis leaf juice, fragrance, methylisothiazolinone.

    Properties: Phyto CHX+KET spray is formulated with chlorhexidine gluconate and ketoconazole, antibacterial and antifungal agents for the management of skin infections. This no-rinse spray also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

  • INDICATIONS & USAGE

    Indications: For use on dogs, cats, and horses only. For the management of bacterial and fungal skin infections responsive to chlorhexidine gluconate and ketoconazole.

    Directions for use: Shake well before use. Apply 1 to 3 times per day for 2 to 3 weeks or as directed by your veterinarian. Spray directly onto the target area(s). If needed, part the hair to allow direct contact with the skin. Massage gently into the skin. Do not allow the animal to lick the treated area.

  • WARNINGS AND PRECAUTIONS

    Cautions: For external use on dogs, cats, and horses only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Wash hands after use.

  • 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

    covetrus

    NDC: 11695-7226-8

    Phyto CHX+KET

    Chlorhexidine gluconate 2%, ketoconazole 1%,

    phytosphingosine salicyloyl 0.02%

    Antiseptic Spray

    Antiseptic spray for dogs, cats and horses

    For animal use only

    Keep out of reach of children

    Net contents: 8 fl oz (237 mL)

    8 ounce bottle label

  • INGREDIENTS AND APPEARANCE
    PHYTO  CHX KET ANTISEPTIC
    chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7226
    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
    SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-7226-8237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2020
    Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
    Registrant - Ceva Sante Animale (261126049)