IDC 20 CONCENTRATE- iodine solution, concentrate

IDC 20 Concentrate by

Drug Labeling and Warnings

IDC 20 Concentrate by is a Animal medication manufactured, distributed, or labeled by WestAgro, Inc., K Klean dba WestAgro, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

A concentrated iodophor for manufacturing use in FDA registered facilities only

ACTIVE INGREDIENT

Active Ingredients:
Titratable Iodine ................................................ 20.0%
INERT INGREDIENTS ......................................... 80.0%
                                            TOTAL: .............. 100.0%

From Nonylphenoxypoly(ethyleneoxy)ethanol-iodine complex

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

! DANGER

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STATEMENT OF PRACTICAL TREATMENT

In case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes.  For eyes, call a physician.  If swallowed, drink promptly a large quantity of water.  Do not induce vomiting.  Avoid alcohol.  Get medical attention.  Remove and wash all contaminated clothing before reuse.

NOTE TO PHYSICIAN:  Probable mucosal damage may contraindicate the use of gastric lavage.  Measures against circulatory shock, respiratory depression and convulsions may be needed.

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Chemtrec Emergency No.

    1-800-424-9300

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Manufactured by:    WESTAGRO
                            11100 N. Congress Avenue
                            Kansas City, MO  64153

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KEEP OUT OF REACH OF CHILDREN

! DANGER

WARNINGS AND PRECAUTIONS

PRECAUTIONARY STATEMENTS:  HAZARDS TO HUMANS AND DOMESTIC ANIMALS

DANGER.  Corrosive.  Avoid breathing vapors.  Causes irreversible eye damage.  Harmful if swallowed.  Do not get in eyes or on clothing.  Avoid contact with skin.  Wear goggles or face shield.  Wash thoroughly with soap and water after handling.  Remove contaminated clothing and wash before reuse.

ENVIRONMENTAL HAZARDS

This product is toxic to fish.  Keep out of lakes, ponds or streams.  Do not contaminate water by cleaning of equipment or disposal of wastes.  Do not discharge into lakes, streams, ponds or public waters unless in accordance with a NPDES permit.  For guidance, contact the regional office of EPA.

STORAGE AND HANDLING

STORAGE AND DISPOSAL

Keep container closed when not in use.  Do not store below 25 deg F or above 100 deg F for extended periods.

Prohibitions:  Do not contaminate water, food or feed by storage or disposal.  Open dumping is prohibited.

Container Disposal:  Triple rinse (or equivalent).  Then offer for recycling, reconditioning or incineration.  May puncture and dispose of in a sanitary landfill or burn, if allowed by State and local authorities.  If burned, stay out of smoke.

INDICATIONS & USAGE

DIRECTIONS FOR USE

Manufacturing instructions must be developed by the formulator prior to use of this product.
Consult Material Safety Data Sheet before using.
NOTE TO FORMULATOR:  Mix well in drum before sampling and before each use.  Avoid contact with soft metals.
IDC 20 CONCENTRATE will flow and mix more easily if a day or two prior to formulating it is gradually warmed to 70 deg F - 100 deg F and then slowly added in a thin stream while mixing.

IDC 20 CONCENTRATE is an iodophor concentrate based on iodine and non-ionic surfactants.  It is specially formulated as a base of manufacturing topical iodine products.
IDC 20 CONCENTRATE contains no phosphates.
IDC 20 CONCENTRATE may be used to manufacture topical animal health care products and related antimicrobials.  IDC 20 CONCENTRATE is not intended for use as a component of iodophor based sanitizers and disinfectants.
It is the responsibility of the distributor of topical antimicrobials to obtain any necessary regulatory approval from the Food and Drug Administration for products formulated from IDC 20 CONCENTRATE which carry specific label directions for treatment or prevention of animal diseases.

SPL UNCLASSIFIED SECTION

0550-A0404        Made in U.S.A.

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0550

CORROSIVE

8

DOT SHIPPING NAME
Corrosive liquid, acidic,
inorganic, N.O.S., (Contains
Iodine), 8, UN 3264, PG II

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NET CONTENTS:

LOT NO:

EXPIRATION DATE:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IDC 20 CONCENTRATE 
iodine solution, concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 33392-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	200 g  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33392-550-60	271.8 kg in 1 DRUM
2	NDC: 33392-550-99	1132.5 kg in 1 TANK
3	NDC: 33392-550-08	23.6 kg in 1 PAIL
4	NDC: 33392-550-50	1246 kg in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2012

Labeler - WestAgro, Inc. (069288728)

Registrant - WestAgro, Inc. (069288728)

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

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

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