GDC-28 CONCENTRATE- iodine solution, concentrate

GDC-28 Concentrate by

Drug Labeling and Warnings

GDC-28 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]

WESTAGROGDC-28TM Concentrate

EN A Concentrated Iodophor for Manufacturing Use

ES Un Iodophor concentrado para la Fabricacion de Uso

ACTIVE INGREDIENT

Active Ingredients:

Titratable Iodine* ...................28.0%

INERT INGREDIENTS ..............72.0%

TOTAL ..................................100.0%

* from glycerin

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FIRST AID:

IF IN EYES: Rinse cautiously with water for several minutes.  Remove contact lenses, if present and easy to do.  Continue rinsing.

IF ON SKIN (or hair):  Remove/Take off immediately all contaminated clothing.  Rinse skin with water/shower.  Wash contaminated clothing before reuse.

IF INHALED:  If breathing is difficult, remove victim to fresh air and keep at rest in a position of comfortable breathing.

IF SWALLOWED:  Rinse mouth. DO NOT induce vomiting.

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CHEM-TREC EMERGENCY #:  1-800-424-9300

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Manufactured by:

WestAgro, Inc.

11100 N. Congress Ave.

Kansas City, MO 64153

Reorder # 1-800-421-1905

Made in U.S.A.

4406 - A0916

HAZARD RATING

4-EXTREME

3-HIGH

2-MODERATE

1-SLIGHT

0-INSIGNIFICANT

HEALTH  3

FIRE  0

INSTABILITY  0

NPE FREE Formula

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4406

NDC # 33392-319

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

! DANGER

MANTENER FUERA DEL ALCANCE DE LOS NINOS

! PELEGRO

WARNINGS AND PRECAUTIONS

Consult Safety Data Sheet Before Using

HAZARD STATEMENTS:

Causes severe skin and eye damage.  May be corrosive to metals.  Avoid contact with skin and eyes.  Wear protective apron, gloves, and goggles or face shield when handling this product.  Wash thoroughly after handling this product.  Harmful if swallowed.  Swallowing product will cause severe burns to lining of throat and stomach.

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE:

Manufacturing instruction must be developed by the formulator prior to use of this product.

Note to formulator:  Mix well in drum before sampling and before each use.  Avoid contact with soft metals.

GDC-28TM Concentrate will flow and mix more easily if a day or prior to formulating it is gradually warmed to 700F - 1000F and then slowly added in a thin stream while mixing.

GDC-28TM Concentrate is an iodophor concentrate based on iodine and glycerin.  It is specially formulated as a base for manufacturing topical iodine products.

GDC-28TM Concentrate contains no phosphates.

GDC-28TM Concentrate may be used to manufacture topical animal health care products and related antimicrobials.  GDC-28TM 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 GDC-28TM Concentrate which carry specific label directions for treatment or prevention of animal diseases.

WARNINGS AND PRECAUTIONS

UN1760

Corrosive liquid, NOS, (Iodine Complex) Liquido corrosivo N.E.P. (Contiene Yodo)

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NET CONTENTS:

LOT NO:

EXPIRATION DATE:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GDC-28 CONCENTRATE 
iodine solution, concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 33392-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	280 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM IODIDE (UNII: F5WR8N145C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33392-319-08	18.9 kg in 1 PAIL
2	NDC: 33392-319-42	159 kg in 1 DRUM
3	NDC: 33392-319-93	731 kg in 1 TANK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2016

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