Label: PHYTO CHX MC ANTISEPTIC- chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo

  • NDC Code(s): 11695-7234-1, 11695-7234-6, 11695-7234-8
  • 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 June 3, 2020

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

  • DESCRIPTION

    PHYTO CHX+MC ANTISEPTIC SHAMPOO

    Active Ingredients: Chlorhexidine gluconate 2%, miconazole nitrate 2%, phytosphingosine salicyloyl 0.05%.

    Inactive Ingredients: Water, lauramine oxide, cocamidopropyl betaine, decyl glucoside, polyacrylate-1 crosspolymer, lactic acid, acetic acid, fragrance, methylchloroisothiazolinone, methylisothiazoline, sodium hydroxide.

    Properties: Phyto CHX+MC antiseptic shampoo is formulated with chlorhexidine gluconate and miconazole nitrate, antibacterial and antifungal agents for skin cleansing.  This low-lather formula also contains phytosphingosine, a pro-ceramide, to help moisturize and support a healthy skin barrier.

  • INDICATIONS & USAGE

    Indications: For dogs, cats, and horses, for the management of bacterial or fungal skin infections responsive to chlorhexidine gluconate and miconazole nitrate.

    Directions for Use: Use 2 to 3 times per week for 2 to 3 weeks, or as directed by your veterinarian.  Shake well before use. 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. 

  • WARNINGS AND PRECAUTIONS

    Cautions: For external use only on dogs, cats, and horses. Avoid contact with the 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
    www.covetrus.com

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

    covetrus

    11695-7234-8

    PHYTO CHX+MC ANTISEPTIC SHAMPOO

    Chlorhexidine gluconate 2%, miconazole

    nitrate 2%, phytosphingosine salicyloyl 0.05%

    Antibacterial and antifungal shampoo for dogs,
    cats, and horses

    FOR ANIMAL USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    Net contents: 8 fl oz (237 mL)

    8 ounce bottle label

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

    covetrus

    11695-7234-6

    PHYTO CHX+MC ANTISEPTIC SHAMPOO

    Chlorhexidine gluconate 2%, miconazole

    nitrate 2%, phytosphingosine salicyloyl 0.05%

    Antibacterial and antifungal shampoo for dogs,
    cats, and horses

    FOR ANIMAL USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    Net contents: 16 fl oz (473 mL)

    16 ounce bottle label

  • PRINCIPAL DISPLAY PANEL - 1 Gallon (3785 mL) Jug

    covetrus

    11695-7234-1

    PHYTO CHX+MC ANTISEPTIC SHAMPOO

    Chlorhexidine gluconate 2%, miconazole

    nitrate 2%, phytosphingosine salicyloyl 0.05%

    Antibacterial and antifungal shampoo for dogs,
    cats, and horses

    FOR ANIMAL USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    Net contents: 1 gallon (3.785 L)

    1 Gallon Jug Label

  • INGREDIENTS AND APPEARANCE
    PHYTO  CHX MC ANTISEPTIC
    chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
    SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-7234-8237 mL in 1 BOTTLE, PLASTIC
    2NDC:11695-7234-6473 mL in 1 BOTTLE, PLASTIC
    3NDC:11695-7234-13785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/03/2020
    Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
    Registrant - Ceva Sante Animale (261126049)