FDA Label for Gemcitabine Hydrochloride
View Indications, Usage & Precautions
Gemcitabine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Evonik Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
On Each Inner Pail. (Generic) Produced Material Label
For every pail, this label is applied:
Produced Material Label
Manufactured by:
Evonik Corporation Tippecanoe Laboratories
1650 Lilly Road, Lafayette, IN 47909 USA
Order:
Material Description:
Item:
Batch:
Caution statement:
Container number:
Shipping Label On Outer Drum.
Bulk for Export Only
Caution: For Manufacturing, processing or repacking. Rx Only.
Gemcitabine hydrochloride
QA383E
Caution: Toxic, skin permeable, mutagen, irritant (eyes), reproductive, and blood.
Batch number:
Manufacture date:
Re-evaluation date:
Manufactured and tested by Evonik Corporation, Tippecanoe Laboratories, 1650 Lilly Road, Lafayette, IN 47909
(Generic) Warehouse Weight Label
As the drum is weighed in the warehouse, this label is applied with the net weight and storage location:
Material number:
Material description:
Batch:
TO:
SU: Storage unit
Quantity: kg
May 2022 Warehouse Kg Label
Gemcitabine Hydrochloride
Put-Away Label
Material Number 99144329
Storage Unit
Net Weight xx Kg
Lot/Batch
Old Material Number QA383E
QR code box
Storage Conditions: Warehouse temperature
Temperature Conditions: 8 to 40°C
Hazards:
Skin permeable. Mutagen. Irritant (eyes). Reproductive. Blood. Highly potent.
Acute toxicity, oral. Acute toxicity, dermal.
Health 2
Fire 1
Reactivity 1
Special R (reproductive hazard)
Evonik Corporation
1650 Lilly Road Lafayette, Indiana 47909 USA
Phone: 765-477-4300 Fax: 765-477-4291
Evonik: Leading beyond Chemistry
Emergency Information: Chemtrec 800-424-9300
Warehouse Kg Elma Dec2022
Gemcitabine Hydrochloride
Put-away label
Material number: 99144329
Storage unit number
Net quantity: KG
QR Code
Lot/Batch number:
Old Material Number: QA383E
Storage Conditions: Warehouse Temperatur
Temperature condition: 8°C to 40°C
Skin permeable. Mutagen. Irritant (eyes). Reproductive. Blood.
Highly potent. Acute toxicity, oral. Acute toxicity, dermal.
Health: 2
Fire: 1
Reactivity: 1
Special: R (reproductive hazard) P (highly potent)
Evonik Corporation
1650 Lilly Road
Lafayette, Indiana 47909 USA
Phone: 765-477-4300
Fax: 765-477-4291
Evonik: Leading Beyond Chemistry
Emergency Phones (Chemtrec, 24 h)
US & CA 1-800-424-9300
Mexico 800-681-9531
Intl. 001-703-527-3887 (collect calls accepted)
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