INSTAMIX IODINE CONCENTRATE IC- iodine, glycerine concentrate

InstaMix Iodine Concentrate IC by

Drug Labeling and Warnings

InstaMix Iodine Concentrate IC by is a Animal medication manufactured, distributed, or labeled by DeLaval Inc., West Agro, Inc., K Klean dba West Agro, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

An iodine concentrate designed for use with InstaMix™ Emollient Concentrate EC using a DeLaval recommended on-site blending unit.

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Iodine............................ 5.2%

Emollient¤ ..................... 8.5%

¤from Glycerin

SPL UNCLASSIFIED SECTION

I²

PART A

NPE

FREE

Formula

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

! CAUTION

WARNINGS

READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

WARNINGS AND PRECAUTIONS

Not For Human Use

Additional Information on Safety Data Sheet

CHEMTREC EMERGENCY NUMBER 1-800-424-9300

INDICATIONS & USAGE

InstaMix™ Iodine Concentrate IC (Part A) is an iodine concentrate exclusively designed for use in combination with InstaMix™ Emollient Concentrate EC (Part B) for on-site blending / production of teat dips.  To be blended with a DeLaval recommended on-site blending unit.

SPL UNCLASSIFIED SECTION

STORAGE AND DISPOSAL

• THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN.
• Avoid contact with food or feed.  Avoid storing near heat or open flame.
• Keep from freezing.
• If product is frozen, thaw in warm room and mix well before using.
• Keep container tightly closed when not in use.
• Do not reuse empty container.
• Rinse empty container before disposing in a safe manner.

INSTRUCTIONS FOR USE

GENERAL INSTRUCTIONS

• Do not use full strength.
• Consult veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
• Do not use teat dip for cleaning and/or sanitizing of dairy equipment.
• Discard any teat sanitizing solution that becomes dirty or contaminated for any reason.
• Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in the control of mastitis.
• To be mixed with InstaMix Emollient Concentrate EC (Part B) using a DeLaval recommended on-site blending unit.  Can be diluted to create 18 formula options.

USE DIRECTIONS

Pre-Dipping

• Remove excess organic debris and forestrip.
• Dip or spray cow's teats with properly diluted teat dip prepared with the DeLaval recommended on-site blending unit.
• Allow a 30 second contact time.
• Dry teats thoroughly with a clean, single-service paper towel.
• Attach milker unit.

Post-Dipping

• Immediately after removing the milker unit, dip or spray each teat with properly diluted teat dip prepared with a DeLaval recommended on-site blending unit.
• Before exposing cow's teats to below freezing temperatures, the teats should be thoroughly dry to reduce the potential of frostbite.  Failure to follow these instructions may result in frozen teats and injured animals.

DILUTION CHART 

% Emollient	0.25% Iodine	0.25% Iodine	0.25 % Iodine	0.5% Iodine	0.5% Iodine	0.5% Iodine	0.75% Iodine	0.75 % Iodine	0.75% Iodine	1.0% Iodine	1.0% Iodine	1.0% Iodine
	InstaMix (PART A) Iodine Conc./Gal.	InstaMix (PART B) Emollient Conc./Gal	Water/Gal.	InstaMix (PART A) Iodine Conc./Gal.	InstaMix (PART B) Emollient Conc./Gal	Water/Gal.	InstaMix (PART A) Iodine Conc./Gal.	InstaMix (PART B) Emollient Conc./Gal	Water/Gal.	InstaMix (PART A) Iodine Conc./Gal.	InstaMix (PART B) Emollient Conc./Gal	Water/Gal.
2	4.58	2.78	92.65	9.16	2.01	88.83	13.74	1.25	85.02	18.32	0.48	81.20
3.5							13.74	3.90	82.36
5	4.48	8.08	87.34	9.16	7.32	83.52	13.74	6.56	79.71	18.32	5.79	75.89
10	4.58	16.93	78.49	9.16	16.17	74.67	13.74	15.41	70.86	18.32	14.64	67.04
12							13.74	18.95	67.32	18.32	18.18	63.50
14										18.32	21.72	59.96
15										18.32	23.50	58.20
20										18.32	32.30	49.40

IMPORTANT!

• 0.25% teat dip must be mixed on demand.
• 0.5% - 1.0% teat dip must be used within two weeks after mixing.
• Discard unused mixtures after above noted times.

SPL UNCLASSIFIED SECTION

FIRST AID

• Contact with product can cause irritation to eyes.  Avoid contact with eyes.
• Eye Contact:  Flush with water.
• If swalled:  Do not induce vomiting.  Call a physician or poison control center immediately.

SPL UNCLASSIFIED SECTION

Manufactured for:  DeLaval, Inc.

11100 N. Congress Avenue

Kansas City, MO 64153

Phone:  816-891-7700

Manufactured by:  WestAgro, Inc.

© 2019, Made in USA

NET CONTENTS:

LOT NO.:

EXP. DATE:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTAMIX IODINE CONCENTRATE IC 
iodine, glycerine concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 55756-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	52 g  in 1 L
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	85 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLOXAMER 335 (UNII: G6DQL26D50)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55756-351-01	208.4 L in 1 DRUM
2	NDC: 55756-351-27	1042.2 L in 1 TANK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/17/2019

Labeler - DeLaval Inc. (173704867)

Registrant - West Agro, Inc. (069288728)

Establishment
Name	Address	ID/FEI	Business Operations
West Agro, Inc.		147528723	manufacture, api manufacture, analysis, label, pack

Establishment
Name	Address	ID/FEI	Business Operations
K Klean dba West Agro, Inc.		002222368	manufacture, api manufacture, analysis, label, pack

Establishment
Name	Address	ID/FEI	Business Operations
West Agro, Inc.		044610140	manufacture, api manufacture, analysis, label, pack

Establishment
Name	Address	ID/FEI	Business Operations
Alliance Dairy Service & Supplies Inc.		117084685	repack