Label: LEGEND S.A.- iodine solution

  • NDC Code(s): 47593-574-17, 47593-574-21
  • Packager: Ecolab Inc.
  • 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 July 12, 2023

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

  • SAFE HANDLING WARNING

    NOT FOR HUMAN USE

    Attention

    For External Use Only

    Wash hands thoroughly after handling.

    Get medical advice/ attention if you feel unwell.

    READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT

    EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect

  • VETERINARY INDICATIONS

    DIRECTIONS:

    LEGEND S.A. CONCENTRATE MUST BE DILUTED BEFORE USE

    DO NOT MIX WITH ANYTHING BUT COOL, POTABLE WATER

    FOR USE ONLY IN A DISPENSING SYSTEM RECOMMENDED BY ECOLAB

    Dilution Parameter: A dilute solution of a 0.5% iodine teat dip will consist of 87.5% potable water and 12.5% Legend S.A. Concentrate by volume. A dilute solution of a 1% iodine teat dip will consist of 75% potable water and 25% Legend S.A. Concentrate by volume.

    IMPORTANT: Do not mix Legend S.A. Concentrate or diluted Legend S.A. Concentrate with any other products unless specified in the product use instructions. If transferred from this container to any other, make sure that the other container is thoroughly pre-cleaned and bears the proper container labeling for Legend S.A. Concentrate.

    If product in dip cup becomes visibly dirty, discard contents and replenish with diluted, ready-to-use product. Do not reuse or return any unused product to the original container.

    Before Milking: Wash teats thoroughly just prior to next milking with appropriate udder wash solution or pre-milking teat dip to avoid contamination of milk. Teats should then be dried with single-service towels. Use proper procedures for udder washing or pre-dipping.

    Application of Diluted Legend S.A. Concentrate

    Directions for Teat Dipping

    Pre-Milk Dipping: Fill teat dip cup with diluted Legend S.A. Concentrate. Before each cow is milked, dip each teat full-length into the teat dip cup containing diluted Legend S.A. Concentrate. Wipe teats dry after dipping using single-service towels to avoid contamination of milk.

    Post-Milk Dipping: Immediately after each milking, dip each teat full-length into the teat dip cup containing diluted Legend S.A. Concentrate. Allow to air dry. Do not wipe. Always use fresh, diluted Legend S.A. Concentrate. Do not turn cows out in freezing weather until teat dip is completely dry.

    Directions for Teat Spraying

    Pre-Milk Spraying: Before each cow is milked, spray entire teat with diluted Legend S.A. Concentrate. Wipe teats after spraying using single-service towels to avoid contamination of milk.

    Post-Milk Spraying: Immediately after each milking, spray entire teat with diluted Legend S.A. Concentrate. Allow to air dry. Do not wipe. Always use fresh, diluted Legend S.A. Concentrate. Do not turn cows out in freezing weather until diluted Legend S.A. Concentrate is completely dry.

    Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving.

    PRECAUTION: Legend S.A. Concentrate is not intended to cure or help the healing of chapped or irritated teats. As with any germicide, irritation or sensitization may occur in sensitive animals. In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian.

    NOTE: Use blended Legend S.A. Concentrate within six (6) months of blended date.

    Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.

  • OTHER SAFETY INFORMATION

    KEEP OUT OF REACH OF CHILDREN

    FOR INDUSTRIAL USE ONLY

    NOT FOR HUMAN USE

    Read other label for directions for use, first aid and precautionary statements

  • Principal Display panel and representative label

    Legend™ S.A. Concentrate

    Iodine Teat Dip Concentrate

    An aid in reducing the spread of organisms which may cause mastitis

    ACTIVE INGREDIENT:

    Titratable Iodine........................................................ 3.6%

    INERT INGREDIENTS:......................................... 96.4%

    (contains propylene glycol, glycerin)

    TOTAL:..................................................................... 100.0%

    Attention |  Atención

    KEEP OUT OF REACH OF CHILDREN

    FOR INDUSTRIAL USE ONLY

    NOT FOR HUMAN USE

    Read other label for directions for use, first aid and precautionary statements

    766871/5301/0217

    56.8 L (15 US GAL)

    6302029

    representative label panel 1

    representative label panel 2

  • INGREDIENTS AND APPEARANCE
    LEGEND S.A. 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:47593-574
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE36 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-574-1756800 mL in 1 PAIL
    2NDC:47593-574-21208000 mL in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/11/2016
    Labeler - Ecolab Inc. (006154611)