Label: DELLA BARRIER 2500- iodine solution

  • NDC Code(s): 55756-336-01, 55756-336-02, 55756-336-27
  • 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 17, 2022

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

  • ACTIVE INGREDIENT

    0.25% Iodine* Barrier Teat Dip with 5.00% Emolient

    Contiene 0.25% de yodo y 5.00% de emolientes

    ACTIVE INGREDIENTS:

    Iodine*.......................0.25%

    *From polyethoxy polypropoxy polyethoxy ethanol-iodine complex

    Emollient**.................5.0%

    **From glycerine and sorbitol

  • SPL UNCLASSIFIED SECTION

    I2

    BARRIER TECHNOLOGY

    NPE FREE Formula

    I-tech

    FREE IODINE TECHNOLOGY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    ! CAUTION

    MANTENER FUERA DEL ALCANCE DE LOS NIÑOS

    ! CUIDADO

  • 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.

    If in Eyes:  Flush with water.  Remove contact lenses, if present, after first 5 minutes.  Then continue rinsing.  Get immedicate 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

  • WARNINGS

    Not For Human Use

    Additional Information on Safety Data Sheet

  • INDICATIONS & USAGE

    GENERAL INSTRUCTIONS

    • Use Della Barrier 2500TM teat sanitizer undiluted.
    • Consult veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
    • Store at room temperature.
    • Do not use teat sanitizer for cleaning or sanitizing dairy equipment.
    • Discard any teat sanitizer solution that becomes dirty or contaminated for any reason.
    • Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in control of mastitis.

    POST-DIPPING

    • Immediately after removing milker unit, dip each teat with Della Barrier 2500TM
    • Allow Della Barrier 2500TM to air dry.  Do not wipe off.
    • Do not expose teats to freezing conditions until they are dry.  
  • SPL UNCLASSIFIED SECTION

    Manufactured for:  DeLaval, Inc.

    11100 N. Congress Avenue

    Kansas City, MO 64153

    Phone: 816-891-7700

    Manufactured by:  WestAgro, Inc.

    ©2020. Made in USA

    NET CONTENTS:

    LOT NO.:

    EXP. DATE:

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DELLA BARRIER 2500 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55756-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE.0025 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POLOXAMER 335 (UNII: G6DQL26D50)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM IODATE (UNII: U558PCS5Z9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55756-336-0256.8 L in 1 PAIL
    2NDC:55756-336-01208.2 L in 1 DRUM
    3NDC:55756-336-271041 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/11/2020
    Labeler - DeLaval (173704867)
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.147528723manufacture, label, pack, api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    K Klean dba WestAgro, Inc.002222368manufacture, label, pack, api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.095906480manufacture, label, pack, api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label