Label: CLX DERM SPOT- chlorhexidine gluconate gel

  • 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 January 12, 2022

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

  • VETERINARY INDICATIONS

    chlorhexidine digluconate antiseptic skin gel for dogs and cats.

  • ACTIVE INGREDIENT

    Active ingredient(s):

    Chlorhexidine digluconate 0.45%

  • INACTIVE INGREDIENT

    Inactive ingredient(s): deionized water, glycerin, hydroxypropyl guar, isodecanol ethoxylated, lanolin ethoxylated, sorbitol, Tris-EDTA.

  • INDICATIONS & USAGE

    Indications: For topical use on dogs and cats only to aid in the management of skin infections associated with micro-organisms that are sensitive to chlorhexidine.

  • DOSAGE & ADMINISTRATION

    Directions for use: Apply topically to affected spots on the skin. Apply 2-3 times per day until skin improves or as directed by your veterinarian. Then, reduce application to weekly. Do not rinse product after application.

  • PRECAUTIONS

    Precautionary statements:

    For external use on dogs and cats only. May cause skin or eye irritation. Avoid getting gel 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. Do not use inside the ear canal. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.

  • SAFE HANDLING WARNING

    Warning: Keep out of reach of children.

  • STORAGE AND HANDLING

    Storage: Store at room temperature. Do not freeze.

  • SPL UNCLASSIFIED SECTION

    Manufacturer:

    iCF™
    Evolution
    of
    Knowledge

    a division of

    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

    iCF™
    Evolution
    of
    Knowledge

    www.icfpet.com

  • PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton

    CLXDerm™

    spot gel

    chlorhexidine digluconate
    antiseptic skin gel

    for dogs and cats

    Developed in Italy

    iCF™
    Evolution of
    Knowledge

    3.38 fl. oz.(100 ml)

    PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLX DERM SPOT 
    chlorhexidine gluconate gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    isodecyl alcohol (UNII: 3160X491M7)  
    Sorbitol (UNII: 506T60A25R)  
    PEG-75 Lanolin (UNII: 09179OX7TB)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-004-031 in 1 CARTON
    1100 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