Label: MONARCH ULTIMATE CONCENTRATE- iodine solution 

  • NDC Code(s): 47593-202-16, 47593-202-21
  • Packager: Ecolab Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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

  • GENERAL PRECAUTIONS

    FOR COMMERCIAL USE ONLY
    KEEP OUT OF REACH OF CHILDREN
    NOT FOR HUMAN USE

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  • CAUTION

    Not for internal use. May cause eye irritation. If swallowed, may cause irritation,
    nausea, stomach distress.

    PRECAUTIONARY STATEMENTS
    No protective equipment is necessary under normal use conditions. If splashing
    may occur, eye protection is recommended.

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  • FIRST AID

    If in Eyes: Immediately flush eyes with plenty of cool, running water. Remove
    contact lenses; then continue flushing for at least 15 minutes, holding eyelids apart.
    If Swallowed: Rinse mouth; then immediately drink 1 or 2 large glasses of water.
    DO NOT induce vomiting. Never give anything by mouth to an unconscious person.

    IF IRRITATION OR DISCOMFORT PERSISTS, CALL A PHYSICIAN.
    FOR EMERGENCY MEDICAL INFORMATION IN USA OR CANADA,
    CALL: 1-800-328-0026.
    FOR EMERGENCY MEDICAL INFORMATION WORLDWIDE,
    CALL: 1-651-222-5352 (IN THE USA).

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  • DIRECTIONS FOR USE

    MONARCH ULTIMATE CONCENTRATE MUST BE DILUTED BEFORE USE.
    DO NOT MIX WITH ANYTHING BUT COOL, POTABLE WATER.
    NOTE:
    Monarch Ultimate Concentrate requires the proper dispenser for dilution. Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.
    Dilution Parameter: A dilute solution of a 0.5% iodine teat dip will consist of 90% potable water and 10% Monarch Ultimate Concentrate by volume.

    Application of Diluted Monarch Ultimate Concentrate
    IMPORTANT:
    Do not mix Monarch Ultimate Concentrate or diluted Monarch Ultimate Concentrate with any other teat dips or other products unless specified in 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 Monarch Ultimate Concentrate.
    If product in dip cup becomes visibly dirty, discard contents and replenish with diluted 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.

    Directions for Teat Dipping
    Pre-Milk Dipping:
    Fill teat dip cup with diluted Monarch Ultimate Concentrate. Before each cow is milked, dip each teat full-length into the teat dip cup containing diluted Monarch Ultimate 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 Monarch Ultimate Concentrate. Allow to air dry. Do not wipe. Always use fresh, diluted Monarch Ultimate 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 Monarch Ultimate 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 Monarch Ultimate Concentrate. Allow to air dry. Do not wipe. Always use fresh, diluted Monarch Ultimate Concentrate. Do not turn cows out in freezing weather until diluted Monarch Ultimate Concentrate is completely dry.
    Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving.
    NOTE: Use blended Monarch Ultimate Concentrate within six (6) months of blended date.

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  • PRINCIPAL DISPLAY PANEL/REPRESENTATIVE LABEL

    ECOLAB
    42105
    Net Contents: 5 U.S. gal/18.93 L

    Monarch Ultimate Concentrate

    Iodine Teat Dip Concentrate

    An Aid in Reducing the Spread of Organisms
    Which May Cause Mastitis

    ACTIVE INGREDIENT:
    Titratable Iodine.........................................................4.5%
    INACTIVE INGREDIENTS: ..................................95.5%
    (Contains an emollient system).

    Ecolab Food and Beverage Division
    Ecolab Inc., 370 Wabasha Street N.
    St. Paul, Minnesota 55102-1390 U.S.A.





    Representative label




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  • INGREDIENTS AND APPEARANCE
    MONARCH ULTIMATE CONCENTRATE 
    iodine solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:47593-202
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (IODINE) IODINE 51.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    PROPYLENE GLYCOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47593-202-16 18930 mL in 1 PAIL
    2 NDC:47593-202-21 208200 mL in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/29/1999
    Labeler - Ecolab Inc. (006154611)
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