Label: 4HOOVES- alkyldimethylbenzylammonium chloride and didecyldimethylammonium chloride concentrate

  • NDC Code(s): 55756-137-01, 55756-137-02, 55756-137-27
  • Packager: Delaval
  • 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 4, 2022

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

  • SPL UNCLASSIFIED SECTION

    Hoof Treatment Concentrate
    For the reduction of prevalence and incidence of digital dermatitis (hairy heel wards), a significant cause of lameness in dairy cows.

    Producto Concentrado Para Tratamiento De Patas
    Para la reduccion de la prevalencia e incidencia de la dermatitis digital, causa significativa de cojeras en vacas lecheras

  • ACTIVE INGREDIENT

    CONTAINS:  n-alkyl dimethyl benzyl ammonium chloride and didecyl dimethyl ammonium chloride, hydrochloric acid

    OTHER INGREDIENTS:  FD and C Yellow No. 5

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    ! DANGER

    MANTENER FUERA DEL ALCANCE DE LOS NINOS

    ! PELIGRO

  • SPL UNCLASSIFIED SECTION

    READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT.  FOR ADDITIONAL INFORMATION, REFER TO THE MATERIAL SAFETY DATA SHEET AVAILABLE FROM YOUR DELAVAL DEALER.

    SI USTED NO PUEDE LEER ESTA ETIQUETA, POR FAVOR PIDA A ALGUIEN MAS QUE SE LA LEA ANTES DE USAR ESTE PRODUCTO.

  • WARNINGS

    Corrosive:  Causes burns to skin, eyes, and mucous membranes.  Avoid contact with skin, eyes, and mucous membranes.  Wear gloves and goggles when handling this product.  Wash thoroughly after handling.  Use with adequate ventilation.

    Harmful if swallowed:  Do not take internally.  Do not taste or swallow.  Swallowing product will cause burns to lining of throat and stomach.

    Flammable liquid and vapor:  Keep away from heat, sparks, and flame.  Keep container closed.  Use only with adequate ventilation.

  • STORAGE AND HANDLING

    STORAGE AND DISPOSAL

    THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN.  Avoid contact with food or feed.  Avoid storing near heat or open flame.  Keep container tightly closed when not in use.  Do not reuse empty container.  Rinse container before disposing in safe manner.

  • SPL UNCLASSIFIED SECTION

    FIRST AID
    In case of contact:  Immediately flush eyes and skin with plenty of water for at least 15 minutes while removing contaminated clothes and shoes.  Get immediate medical attention.  Wash clothes before reuse.

    If swallowed:  Do not induce vomiting.  Give victim large amounts of milk or water.  Get immediate medical attention.  Never give anything by mouth to an unconscious person.

    If inhaled:  Immediately move victim to fresh air.  Get medical attention.

  • SPL UNCLASSIFIED SECTION

    CHEM-TREC EMERGENCY NUMBER
    1-800-424-9300

  • INDICATIONS & USAGE

    DIRECTIONS FOR USE

    4HOOVES is a synergetic mixture of a new generation of quaternary ammonium compounds and acid.  4HOOVES does not contain antibiotics, formaldehyde, copper sulfate or other heavy metal.  With a complete hoof management program, 4HOOVES is proven to reduce the prevalence and incidence of digital dermatitis.

    Not for human use.  Do not use at full strength.  Read and follow label instructions carefully.  Dilute according to directions below.

    • Consult a veterinarian for proper diagnosis of digital dermatitis before using this product.
    • For best results, use this product as part of a complete hoof care program.

    USAGE AND DOSAGE INSTRUCTIONS

    This product needs to be diluted with water and can be used in a footbath or as a spray.  The use of pre-bath with Delaval Hoof Cleaner HC40 is highly recommended.

    Footbath:

    Footbath dilutions are based on treatment of 200 cows, after which it is recommended the footbath solution be discarded and replaced with fresh 4HOOVES footbath solution.  For a 50 gallon footbath, mix thoroughly 0.5 gallons of 4HOOVES with 49.5 gallons of water (1% solution).  For best results, use daily.  If gallon capacity of footbath is unknown, use the following formula to calculate the volume of the footbath:

    Inside Length (in.) x Inside Width (in.) x Fluid Height (in.) divided by 231 = Gallon Capacity of Footbath

    Spray-On Applications:

    Prepare a fresh solution of 4HOOVES mixing thoroughly 1 oz with 39 oz of water (2.5% solution).  Rinse hooves thoroughly with water or DeLavel Hoof Cleaner HC40 to remove mud and manure.  Then thoroughly saturate each hoof and heel of the cow with the solution.  Spray until favorable results are observed.  Should solution become contaminated, discard and prepare fresh 4HOOVES spray-on solution.

  • SPL UNCLASSIFIED SECTION

    DOT SHIPPING NAME:
    UN2920, Corrosive liquid, flammable, n.o.s. (Hydrochloric Acid, Quaternary Ammonium Compound, Ethanol), 8(3), PG II

    CORROSIVE

    8

  • SPL UNCLASSIFIED SECTION

    Manufactured for: DeLaval, Inc.
    11100 N. Congress Avenue
    Kansas City, MO 64153
    Phone: 816-891-7700
    Manufactured by: WestAgro, Inc.
    ©2018, Made in USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    4HOOVES 
    alkyldimethylbenzylammonium chloride and didecyldimethylammonium chloride concentrate
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55756-137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride159 g  in 1 L
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE238.6 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55756-137-0256.8 L in 1 DRUM
    2NDC:55756-137-01208.2 L in 1 DRUM
    3NDC:55756-137-271040 L in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2011
    Labeler - Delaval (173704867)
    Registrant - WestAgro, Inc. (069288728)
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.147528723analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    K Klean dba WestAgro, Inc.002222368analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.095906480analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label