Label: CONFIDENCE 1-3- iodine solution

  • NDC Code(s): 57906-455-01, 57906-455-27
  • 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 20, 2022

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  • SPL UNCLASSIFIED SECTION

    7455

    NDC: 57906-455

  • INDICATIONS & USAGE

    Concentrated Iodine Teat Sanitizer / Sellador Concentrado para Pezones

    Aids in reducing the spread of mastitis-causing organisms

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    MANTENER FUERA DEL ALCANCE DE LOS NINOS

  • WARNINGS

    ! CAUTION      ! CUIDADO

    NOT FOR HUMAN USE

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

  • ACTIVE INGREDIENT

    Contains: 4.00% available iodine*

    * from a nonionic surfactant iodine complex.

  • SPL UNCLASSIFIED SECTION

    FIRST AID:

    Contact with product can cause irritation to eyes.  Keep out of eyes.

    If in Eyes:  Flush with water.  Remove contact lenses after first 5 minutes, if present, then continue flushing.

    If Swallowed:  Drink large quantities of water and induce vomiting.

  • 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 warm room and shake well before using. Do not reuse empty container. Rinse empty container before disposing in a safe manner.

  • WARNINGS AND PRECAUTIONS

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

  • INDICATIONS & USAGE

    DIRECTIONS:

    Directions for Dilutions:
    Add 1 gallon CONFIDENCE 1-3 to 3 gallons of water and agitate until thoroughly mixed.  Proper dilution of CONFIDENCE 1-3 will yield a 1% iodine teat dip sanitizer with 3% emollients.  Failure to follow these mixing instructions could cause injury to your animals or reduce the effectiveness of the product as a teat dip.

    Use Directions:

    Do not use full strength. Consult your veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped. Discard any teat dipping solution that becomes dirty or contaminated for any reason. Clean and sanitize teats before milking to avoid contamination and assist in control of mastitis.

    Pre-Dipping: Remove excess organic debris and forestrip.  (If water is used, use a minimal amount and dry thoroughly with clean, single service paper towels before forestripping). Dip or spray cow's teats with properly diluted CONFIDENCE 1-3. Allow a 30 second contact time. Dry teats thoroughly with a clean, single-service paper towel. Attach milker unit.

    Post-Dipping: Immediately after removing the milker unit, dip or spray each teat with properly diluted Universal CONFIDENCE 1-3. Before exposing cows to below freezing temperatures, the teats should be thoroughly dry to reduce the potential of frostbite.  Failure to follow these instructions may result in frozen teats and injured animals.

  • SPL UNCLASSIFIED SECTION

    NET CONTENTS:

    LOT NO.:

    EXP. DATE:

  • SPL UNCLASSIFIED SECTION

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

    Chemtrec Emergency Number
    1-800-424-9300

    NPE FREE Formula

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CONFIDENCE 1-3 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57906-455
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE40.0 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    C9-11 PARETH-8 (UNII: 80E6PSE1XL)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57906-455-01208.4 L in 1 DRUM
    2NDC:57906-455-271042.2 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2012
    Labeler - Universal (605831627)
    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