Note: Ingredients listed on restricted chemical lists
EC/CAS
100-51-6
Name of the chemical
Benzyl Alcohol
Concentration
N/A
EC/CAS
9005-65-6
Name of the chemical
polyethyleneglycol sorbitan monooleate
Concentration
N/A
General Information
Version
12/28/2020
Revision date
2020-12-28
Product name
Fulvestrant Injection
Manufacturer Name
Fresenius Kabi USA, LLC
Icons in SDS
Company Information
company name
Fresenius Kabi USA, LLC
GHS Information
Signal word
DANGER!
Hazard Codes
Hazard statements (CLP)
H302, H360, H362
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
Classification of the chemical in accordance with CFR 1910.1200(d)(f) GHS Pictograms
Signal word
DANGER! GHS Class Reproductive Toxicity, Category 1B Acute Toxicity Oral, Category 4 Hazard Statements May damage fertility or the unborn child May cause harm to breast-fed children Harmful if swallowed
Precautionary statements
Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapours/spray. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. IF exposed or concerned: Get medical advice/attention. Store locked up. Wear protective gloves/protective clothing/eye protection/face protection. IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. Rinse mouth. Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations. Hazards not otherwise classified that have been identified during the classification process: Emergency Overview: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.
Principle Routes of Exposure
Inhalation Ingestion Eye contact Skin Absorption. Injection.
Potential health effects
Eye: Contact with eyes may cause irritation. Skin: May cause skin irritation. Inhalation: May cause irritation of respiratory tract. Ingestion: May cause irritation. Signs/Symptoms: Potential adverse reactions from prescribed doses and overdoses are described in the package insert. Aggravation of Pre-Existing
Medical Conditions Generally Aggravated by Exposure
Accidental Exposure Individuals who are pregnant or have a known Conditions: hypersensitivity to the drug or to any of its components
2.1 Classification of the substance or mixture
GHS Pictograms: Signal Word: DANGER! GHS Class: Reproductive Toxicity, Category 1B Acute Toxicity Oral, Category 4. Hazard Statements: May damage fertility or the unborn child. May cause harm to breast-fed children. Harmful if swallowed.
