ICON 5000 II- iodine liquid

ICON 5000 II by

Drug Labeling and Warnings

ICON 5000 II by is a Animal medication manufactured, distributed, or labeled by IBA, Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Iodine Complex:...........................................25.00%

(Provide a full .5% available iodine when used at the recommended dilution ratio)

INERT INGREDIENTS:

Triple Emollient Syste (As Humectants And Skin Conditioners):..........................................20.00%

(Provides a total of 2.0% emollients at the recommended dilution ratio)

 Other Inerts................................................................................................................55.00%

(Includes Buffering Agents, Stabilizing Agents, And Surfactants)

TOTAL:.......................................................................................................................100.00%

GENERAL PRECAUTIONS

GENERAL RECOMMENDATIONS

1. Use teat dip applicators made of plastic or other non-corrosive materials. Do not use cups made of aluminum.

2. When soluiton in the teat dip cup becomes dirty and/or noticebly loses color. discard remaining contents and refill cup with fresh teat dip.

3. Do not use this product for cleaning or sanitizing equipment.

4. Wash teat dip cups after each milking.

   CAUTION

KEEP OUT OF REACH OF CHILDREN. AVOID CONTACT WITH FOOD. DO NOT TAKE INTERNALLY.

OTHER SAFETY INFORMATION

FIRST AID: IF TAKEN INTERNALLY, DRINK LARGE QUANTITIES OF WATER AND GET IMMEDIATE MEDICAL ATTENTION. IN CASE OF CONTACT WITH EYES, FLUSH LIBERALLY WITH TEPID WATER AND  GET MEDICAL ATTENTION. NEVER GIVE ANYHTING BY MOUTH TO AN UNCONSCIOUS PERSON.

                                  FOR MEDICAL EMERGENCIES CALL 1-303-623-5716

INDICATIONS & USAGE

RECOMMENDED PROCEDURES FOR TEAT SANITATION

A. PRE-MILKING (PRE-DIPPING)

1. Remove visible soils from the teats.

2. Onserve foremilk by stripping two or three streams of milk into a strip cup.

3. Dip or spray teh cow's teats full length with diluted ICON 5000 II Teat Dip.

4. Wait approximately 30 seconds.

5. Remove all teat dip by thoroughly drying the teats and teat orifices with a clean, single service paper towel(s).

6. Attach milking unit

B.POST -MILKING (POST-DIPPING)

1. Immediately after milking, dip or spray all teats full length with diluted ICON 5000 II Teat Dip. Ensure good coverage of all sides of the teats and teat orifices.

Dilute 1 part ICON 5000 II TEAT DIP per 9 parts potable , tepid water.

WARNINGS

                                                          WARNING

ICON 5000 II TEAT DIP CONCENTRATE MUST BE DILUTED BEFORE USE. DO NOT MIX WITH ANYTHING BUT POTABLE WATER.

DO NOT RETURN TEAT DIP LEFT IN THE TEAT DIPPER TO STORAGE CONTAINER.

ENSURE THAT DIPPED TEATS ARE DRY BEFORE EXPOSING THE ANIMALS TO WEATHER CONDITIONS WHICH MAY CAUSE DAMGE TO THE TEATS.

Icon 5000 II - NPE Free

Icon 5000 II NPE Free

INGREDIENTS AND APPEARANCE

ICON 5000 II 
iodine liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 29983-1018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	0.5 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29983-1018-4	21.61 kg in 1 PAIL
2	NDC: 29983-1018-6	64.84 kg in 1 DRUM
3	NDC: 29983-1018-8	237.75 kg in 1 DRUM
4	NDC: 29983-1018-9	1188.75 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/27/2014

Labeler - IBA (019494160)

Registrant - IBA (019494160)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture, api manufacture, pack