IODOSHIELD ACTIVE- iodine concentrate

Iodoshield Active by

Drug Labeling and Warnings

Iodoshield Active by is a Animal medication manufactured, distributed, or labeled by Farmers Industries (New Zealand) Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Iodine based teat sanitizer with Manuka honey from New Zealand
Spray or Dip concentrate
For Commercial Use Only

An aid in reducing the spread of organisms which may cause bovine mastitis.
The product contains the active ingredient at 0.19 pounds per gallon.

USE RATES

FOR ROUTINE SPRAY OR DIP APPLICATIONS
Dilute 1 part FIL Iodoshield Active with 9 parts water.

IN EARLY LACTATION OR INCLEMENT WEATHER CONDITIONS
Dilute 1 part FIL Iodoshield Active with 4 parts water.

GENERAL INSTRUCTIONS

Make up use solutions in clean plastic or stainless steel containers using potable water. Use solutions are reasonably stable if stored in a clean and contamination free environment. However, it is recommended that only sufficient product for a week's use should be made up at one time.

Apply to teats as soon as possible after cup removal. Ensure that the whole teat surface is covered. This product contains a high level of emolliency and generally should not need additional emollient. PRECAUTION: As with any germicide, irritation may occur in sensitive animals. If irritation occurs, discontinue use and consult your veterinarian.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS (AND DOMESTIC ANIMALS)

Prolonged or frequently repeated skin contact may cause allergic reaction in some individuals. Remove contaminated clothing and wash before reuse.

CAUTION

Causes moderate eye irritation. Avoid contact with eyes, skin or clothing. Wear protective eyewear (Goggles, face shield or safety glasses). Harmful if swallowed or absorbed through skin or inhaled. Avoid breathing spray mist. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Wear rubber gloves when handling or applying.

FIRST AID

IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Call a poison control center or doctor for treatment advice.

IF SWALLOWED: Call a poison control center or doctor immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to by a poison center or doctor.

IF ON SKIN: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. Call a poison control center or doctor for treatment.

IF INHALED: Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. Call a poison control center or doctor for further treatment.

Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-328-0026 for emergency medical treatment information.

ENVIRONMENTAL HAZARDS

Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NDPES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority.

For guidance contact your State Water Board or Regional Office of the EPA. Do not contaminate water by cleaning of equipment or disposal of waste.

STORAGE AND DISPOSAL

Do not contaminate water, food or feed by storage or disposal. Open dumping is prohibited. Do not reuse empty container. Protect from freezing.

PRODUCT STORAGE: Store the product in a dry and cool place, where it is not reachable by children.

PRODUCT DISPOSAL: Wastes resulting from use of this product may be disposed of on site or at an approved waste disposal facility.

CONTAINER DISPOSAL: Do not reuse containers. Triple rinse containers when empty. Add rinses to use solutions.

GENERAL: Consult federal, state, or local disposal authorities for approved alternative procedures such as limited open burning.

SPL UNCLASSIFIED SECTION

Manufactured by: Farmers Industries (New Zealand) Limited, 72 Portside Drive, PO Box 4144 Mt Maunganui, New Zealand.

TEL +64 7 575 2162 WWW.FIL.CO.NZ

Distributed by FIL Agritech, LLC 5983 US Rte 11 Homer, NY 13077

TOLL FREE 1-800-680-3167 WWW.FILAGRITECH.COM

PRINCIPAL DISPLAY PANEL - 20 L Bottle Label

CAUTION
KEEP OUT OF REACH OF CHILDREN

FIL

FARM INNOVATION / ANIMAL HEALTH

IODOSHIELD
ACTIVE

Contains 2.2% Iodine and 97.8% other ingredients

Iodine based teat sanitizer with
Manuka honey from New Zealand
Spray or Dip concentrate
For Commercial Use Only

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

WWW.FIL.CO.NZ

INGREDIENTS AND APPEARANCE

IODOSHIELD ACTIVE 
iodine concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51546-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
iodine (UNII: 9679TC07X4) (iodine - UNII:9679TC07X4)	iodine	86.2 g  in 4.55 L

Inactive Ingredients
Ingredient Name	Strength
sorbitol (UNII: 506T60A25R)
honey (UNII: Y9H1V576FH)
water (UNII: 059QF0KO0R)
lanolin (UNII: 7EV65EAW6H)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51546-001-02	20 L in 1 BOTTLE
2	NDC: 51546-001-20	200 L in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2010

Labeler - Farmers Industries (New Zealand) Limited (590180329)

Establishment
Name	Address	ID/FEI	Business Operations
Farmers Industries (New Zealand) Limited		590180329	MANUFACTURE