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#
Contacts and useful links#
Label contents#
Full prescribing information#
WESTAGROGDC-28TM Concentrate
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33392-319-08 | GDC-28 Concentrate | 18.9 kg in 1 PAIL | SOLUTION, CONCENTRATE | 18.9 | 4 | |
| 33392-319-42 | GDC-28 Concentrate | 159 kg in 1 DRUM | SOLUTION, CONCENTRATE | 159 | 4 | |
| 33392-319-93 | GDC-28 Concentrate | 731 kg in 1 TANK | SOLUTION, CONCENTRATE | 731 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- GDC-28 Concentrate
- Iodine
- GLYCERIN
- WATER
- SODIUM IODIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 33392-319 | 33392-319-08, 33392-319-42, 33392-319-93 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IODINE | 9679TC07X4 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM IODIDE | F5WR8N145C | IACT |
Source Document#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
