Label: CLX DERM- chlorhexidine gluconate shampoo

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 11, 2022

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  • VETERINARY INDICATIONS

    ClxDerm™ 4% chlohexidine
    digluconate antiseptic shampoo
    for dogs and cats

  • SAFE HANDLING WARNING

    Warning: Keep out of reach of children.

  • Properties:

    ClxDerm™ 4% chlohexidine digluconate antiseptic shampoo designed for cleansing the skin of dogs and cats. Chlorhexidine, the active ingredient in ClxDerm™ shampoo 4%, has been proven effective against a broad-spectrum of micro-organisms sensitive to chlorhexidine. The use of ClxDerm™ 4% chlohexidine digluconate antiseptic shampoo will aid in the management of skin infections, supporting a healthy skin barrier.

  • DOSAGE & ADMINISTRATION

    Directions for use: Wet your pet with warm water and apply shampoo. Massage into wet haircoat. Allow to remain on haircoat for 5-10 minutes before rinsing thoroughly with clean water. Repeat as needed. To improve skin condition, shampoo 1 to 2 times per week in a 1 to 2 week period, or as directed by your veterinarian. To maintain healthy skin, shampoo at least once per month or as directed by your veterinarian.

  • Precautionary statements:

    For external use on dogs and cats only. May cause skin or eye irritation. Avoid getting shampoo in your pet's eyes. In case of contact with eyes, rinse thoroughly with water and consult a veterinarian. If skin irritation occurs and persists, discontinue use and contact your veterinarian. Consult a veterinarian before using on pregnant, lactating or breeding animals; puppies; kittens; or animals with a pre-existing medical condition. Use with caution in older animals. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.

  • STORAGE AND HANDLING

    Storage: Store at room temperature. Do not freeze.

  • Composition:

    Active ingredient(s):

    Chlorhexidine digluconate 4%.

    Inactive ingredient(s): deionized water, fragrance, glycerin, hydroxypropyl guar, isodecyl alcohol ethoxylate, lanolin ethoxylated, lauramine oxide, myristamine oxide propylene glycol, Tris-EDTA.

  • Indications:

    For use on dogs and cats only to maintain healthy skin and hair and to enhance hygiene. Aids in the management of skin infections associated with micro-organisms that are sensitive to chlorhexidine.

  • SPL UNCLASSIFIED SECTION

    www.icfpet.com

    Manufacturer:

    iCF™
    Evolution     of
    Knowledge

    a division of nextmune

    NEXTMUNE ITALY S.R.L.
    Via G.B. Benzoni, 50 - 26020
    PALAZZO PIGNANO (CR) Italy
    Tel. +39 0373 982024;
    +39 0373 938345
    e-mail:info@icfsrl.it
    customercare@drnsrl.it

    Distributor:
    Nextmune US, LLC
    2801 S. 35th St.,
    Phoenix, AZ 85034
    480-464-8971

    made
    in Spain

  • PRINCIPAL DISPLAY PANEL - 250 ml Bottle Carton

    CLXDerm™

    4%
    chlohexidine
    digluconate

    Antiseptic shampoo
    for dogs and cats

    Developed in Italy

    iCF™
    Evolution of
    Knowledge

    8.45 fl. oz.(250 ml)

    PRINCIPAL DISPLAY PANEL - 250 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLX DERM 
    chlorhexidine gluconate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    isodecyl alcohol (UNII: 3160X491M7)  
    PEG-75 Lanolin (UNII: 09179OX7TB)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-001-011 in 1 CARTON
    1250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2021
    Labeler - Nextmune AB (352950223)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXTMUNE Italy SRL435856461MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Medichem SA464043381API MANUFACTURE
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