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Animal NDC 33392-319-08 Gdc-28 Concentrate

Iodine

Animal Product Information

Field Name Field Value
Animal NDC Code 33392-319-08
Proprietary Name Gdc-28 Concentrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Iodine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Westagro, Inc.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Iodine
Inactive Ingredient(s)
  • GLYCERIN (PDC6A3C0OX)
  • WATER (059QF0KO0R)
  • SODIUM IODIDE (F5WR8N145C)
  • GLYCERIN (PDC6A3C0OX)
  • WATER (059QF0KO0R)
  • SODIUM IODIDE (F5WR8N145C)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Gdc-28 Concentrate Images

Gdc-28 Concentrate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Westagrogdc-28Tmconcentrate



EN A Concentrated Iodophor for Manufacturing Use

ES Un Iodophor concentrado para la Fabricacion de Uso


Otc - Active Ingredient



Active Ingredients:

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

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

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

* from glycerin


Other



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.

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

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

4406

NDC # 33392-319

NET CONTENTS:

LOT NO:

EXPIRATION DATE:


Otc - 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.

UN1760

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


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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.