GDC-28 Concentrate

Manufacturer
WestAgro, Inc. | K Klean dba WestAgro, Inc.
Effective date
2021-12-15
Label type
OTC ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:41:13

Label at a glance#

ProductGDC-28 Concentrate
Active ingredientIODINE
Label structure12 sections

Label contents#

Full prescribing information#

WESTAGROGDC-28TM Concentrate

OTC - PURPOSE SECTION

EN A Concentrated Iodophor for Manufacturing Use

ES Un Iodophor concentrado para la Fabricacion de Uso

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

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

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

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

* from glycerin

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

4406

NDC # 33392-319

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

! DANGER

MANTENER FUERA DEL ALCANCE DE LOS NINOS

! PELEGRO

WARNINGS AND PRECAUTIONS SECTION

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 SECTION

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 SECTION

UN1760

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

SPL UNCLASSIFIED SECTION

NET CONTENTS:

LOT NO:

EXPIRATION DATE:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33392-319-08GDC-28 Concentrate18.9 kg in 1 PAILSOLUTION, CONCENTRATE18.94
33392-319-42GDC-28 Concentrate159 kg in 1 DRUMSOLUTION, CONCENTRATE1594
33392-319-93GDC-28 Concentrate731 kg in 1 TANKSOLUTION, CONCENTRATE7314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33392-319GDC-28 CONCENTRATE (IODINE) SOLUTION, CONCENTRATE [WESTAGRO, INC.]43 package rows20211216_29aa9d2c-528e-45cf-b5e7-27dd4de87d0c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33392-31933392-319-08, 33392-319-42, 33392-319-93

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
IODINE9679TC07X4ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM IODIDEF5WR8N145CIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IodineIODINENice-Pak Products, LLC857f13fe-51c9-4e5b-b5e2-a981dedabf712026-03-12Warnings, Adverse reactionsName fallback
generic name: IODINE
IodineIODINEUnited Natural Foods, Inc. dba UNFI8e840855-d210-4a99-b73f-6c69dcf2b6fb2026-02-16WarningsName fallback
generic name: IODINE
IODDO IODINEIODINEEVI LABS4af8552c-1f2b-84ad-e063-6394a90abb622026-02-16WarningsName fallback
generic name: IODINE
IodineIODINEWalgreen Co.d3d44c9f-4eb6-4e5b-9943-c0f80f06952d2026-02-12Warnings, Adverse reactionsName fallback
generic name: IODINE
IodiumIODINEBoiron85cd5e7a-52b6-0bb7-e053-2a91aa0aaa142023-11-13Name fallback
generic name: IODINE
IodiumIODINEBoiron85cd0c27-7859-5fd8-e053-2a91aa0a7c692023-11-13Name fallback
generic name: IODINE
IodiumIODINEBoiron85cd0c27-782d-5fd8-e053-2a91aa0a7c692023-11-13Name fallback
generic name: IODINE
IodiumIODINEBoiron724cb010-7c5d-11e6-8589-424c583030312023-11-13Name fallback
generic name: IODINE
IodiumIODINEBoiron85cd3f96-b800-f192-e053-2991aa0aee982023-02-20Name fallback
generic name: IODINE
IodiumIODINEBoiron85cd5e7a-52a7-0bb7-e053-2a91aa0aaa142023-01-23Name fallback
generic name: IODINE
IodiumIODINEBoiron85ccdc3f-5dd9-a5b1-e053-2a91aa0a8a0c2023-01-05Name fallback
generic name: IODINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.