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.
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- GENERAL PRECAUTIONS
FOR COMMERCIAL USE ONLYClose
KEEP OUT OF REACH OF CHILDREN
NOT FOR HUMAN USE
Not for internal use. May cause eye irritation. If swallowed, may cause irritation,
nausea, stomach distress.
No protective equipment is necessary under normal use conditions. If splashing
may occur, eye protection is recommended.
- 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.Close
FOR EMERGENCY MEDICAL INFORMATION IN USA OR CANADA,
FOR EMERGENCY MEDICAL INFORMATION WORLDWIDE,
CALL: 1-651-222-5352 (IN THE USA).
- 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 SprayingClose
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.
- PRINCIPAL DISPLAY PANEL/REPRESENTATIVE LABEL
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
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.
- INGREDIENTS AND APPEARANCE
MONARCH ULTIMATE CONCENTRATE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:47593-202 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 51.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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)