Label: CONFIDENCE 0.10-2- iodine concentrate

  • NDC Code(s): 57906-469-01, 57906-469-27
  • Packager: Universal
  • 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 21, 2022

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

  • WARNINGS AND PRECAUTIONS

    Confidence™ 0.10-2

    A concentrate designed for use with an on-site blending unit / Un concentrado diseñado para usarse con una unidad de mezcla en el sitio

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

    NOT FOR HUMAN USE

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:

    Iodine * ................................... 0.42% w/w

    After dilution according to directions

    Iodine * .................................. 0.1%

    * From Polyethoxy polypropoxy polyethoxy ethanol-iodine Complex

    pH 5 minimum

  • 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, then continue flushing.  Get medical attention if irritation develops and persists.

    If Swallowed:  Do not induce vomiting.  Call a physician or poison control center immediately.

  • 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 from freezing.  If product is frozen, thaw in a warm room and mix well before using.  Keep container tightly closed when not in use.  Do not reuse empty container. Rinse empty container before disposing in a safe manner.

  • GENERAL PRECAUTIONS

    Read and understand all label instructions before using this product.  For additional information, refer to the Safety Data Sheet (SDS) available from your Universal representative.

  • PURPOSE

    • Pre-dip, post-dip.  The only dip you need.
    • Elevated free iodine for fast kill of mastitis-causing organisms.
    • Unique pH balance formula has glycerin plus cosmetic grade complexors for excellent skin conditioning.
    • Proven effective in reducing the incidence of mastitis.
    • Contains food grade ingredients to eliminate residue concerns
  • INDICATIONS & USAGE

    DIRECTIONS FOR USE

    GENERAL INSTRUCTIONS

    • Dilute before using. See "Directions for Dilution".
    • Consult your veterinarian before using teat dip on a cow with sore or chapped teats.
    • Thoroughly clean and sanitize teat dip cup before each miling.  Use fresh teat dip for each milking.  Dip solution should be changed if it becomes visibly dirty or if sediment is introduced.  Do not pour used teat dip back into original container.
    • Do not use Confidence™ 0.10-2 for sanitizing equipment.

    DIRECTIONS FOR DILUTION

    Automatic Blending

    • Designed for use with a DeLaval recommended on-site blending unit.  When diluted, Confidence™ 0.10-2 will yield a ready-to-use 0.1% iodine teat dip with 2% glycerin.

    Manual Blending

    • Confidence™ 0.10-2 is a concentrate and must be diluted before use.  Failure to follow the following instructions may result in a product which may not be effective as a teat dip or which may cause injury to animal.
    • Add three (3) gallons of potable water to one (1) gallon of Confidence™ 0.10-2 to a blending container.
    • Mix thoroghly by shaking closed blending container.
    • When properly diluted, one gallon of Confidence™ 0.10-2 will yield four (4) gallons of a ready-to-use 0.1% iodine teat dip with 2% glycerin.

    PRE-DIPPING

    • Made sure udder and teats are clean and dry.
    • Check foremilk and udder for mastitis.
    • Dip or spray cow's teats with properly diluted Confidence™ 0.10-2.
    • Allow 15 to 30 seconds contact time.
    • Dry cow's teat with a single-service paper towel before milking.
    • Attach milker unit.

    POST DIPPING

    • Immediately after removing inflations, clip or spray cow's teats with properly diluted Confidence™ 0.10-2.  Do not wipe.
    • If outside temperature is below freezing, allow teat dip to air-dry on cow's teats before the cow leaves the parlor; or allow teat dip to remain on cow's teats before cow leaves the parlor then dry teats with a single service paper towel.  Failure to follow these directions may result in frozen teats and injured animals. 
  • SPL UNCLASSIFIED SECTION

    Chemtrec Emergency Number

    1-800-424-9300

    NPE Free Formula

  • SPL UNCLASSIFIED SECTION

    NET CONTENTS:        US GAL (        L)

    LOT NO.:

    EXP. DATE:

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CONFIDENCE 0.10-2 
    iodine concentrate
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57906-469
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE.0042 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLOXAMER 335 (UNII: G6DQL26D50)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM IODIDE (UNII: F5WR8N145C)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    SODIUM IODATE (UNII: U558PCS5Z9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57906-469-01216 kg in 1 DRUM
    2NDC:57906-469-271080 kg in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/06/2021
    Labeler - Universal (605831627)
    Registrant - WestAgro, Inc. (069288728)
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.147528723api manufacture, manufacture, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    K Klean dba WestAgro, Inc.002222368api manufacture, manufacture, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.095906480api manufacture, manufacture, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label