Label: DELLA SOFT ENHANCED- iodine solution

  • NDC Code(s): 55756-268-01, 55756-268-02, 55756-268-08, 55756-268-27
  • 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 September 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Pre and post teat sanitizer

    Selladores pre y pos ordeno

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Iodine .......................................... 0.5%
    from polyethoxy polypropoxy polyethoxy ethanol-iodine complex
    pH 4 minimum

    US Patent Nos.: 5,368,868

  • SPL UNCLASSIFIED SECTION

    KEEP OUT OF REACH OF CHILDREN

    ! CAUTION

    MANTENER FUERA DEL ALCANCE DE LOS NINOS

    ! CUIDADO

  • SPL UNCLASSIFIED SECTION

    1268

    NDC 55756-268

  • SPL UNCLASSIFIED SECTION

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

    READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

  • SPL UNCLASSIFIED SECTION

    FIRST AID

    Contact with product can cause irritation to eyes.  Avoid contact with eyes.
    Eye Contact:  Flush with water.  Remove contact lenses, if present, after first 5 minutes.  Then continue rinsing.  Get immediate medical attention.
    If Swallowed:  Do not induce vomiting.  If victim is fully conscious, give a cupful of water.  Never give anything by mouth to an unconscious person.  Get immediate medical attention.

  • 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.  If product has frozen, thaw in a warm room and shake well before use.  Do not reuse empty container.  Rinse empty container before disposing of in a safe manner.  Do not store in direct sunlight.

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Not For Human Use

    Additional Information on Material Safety Data Sheet

  • INDICATIONS & USAGE

    GENERAL INSTRUCTIONS

    • Della Soft Enhanced is a premium 0.5% iodine teat dip with 2% emollient.
    • Use Della Soft Enhanced teat sanitizer at full strength.  Do not dilute.
    • Consult a veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
    • Discard any teat sanitizing solution that becomes dirty or contaminated for any reason.
    • Do not use teat dip for cleaning and/or sanitizing of dairy equipment.
    • Do not pour used teat dip back into original container.
    • Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in the control of mastitis.
    • Thoroughly clean and sanitize teat dip foaming cup before each milking.  Use fresh teat dip for each milking.

    PRE-DIPPING

    • Remove excess organic debris and forestrip.  (If water is used, use a minimal amount and dry thoroughly with a clean, single-service paper towel before forestripping.)
    • Dip or spray cow's teats with Della Soft Enhanced teat sanitizer.
    • Allow a 30 second contact time.
    • Dry teats thoroughly with a clean, single-service paper towel.
    • Attach milker unit.

    POST-DIPPING

    • Immediately after removing milking unit, dip or spray teats with Della Soft Enhanced teat sanitizer.   Apply an ample coat to each teat.
    • Before exposing cows to below-freezing temperatures, the teats should be thoroughly dry to reduce the potential of frostbite.  Failure to follow these instruction may result in frozen teats and injured animals.
  • 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

    NET CONTENTS:

    LOT NO.:

    EXP. DATE:

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DELLA SOFT ENHANCED 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55756-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE5.1 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55756-268-0819 L in 1 PAIL
    2NDC:55756-268-0256.8 L in 1 PAIL
    3NDC:55756-268-01208.4 L in 1 DRUM
    4NDC:55756-268-271042.2 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2012
    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
    Graham Dairy Supply Inc014157770repack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    JBZ Dairy Advantage Inc016914287repack