Note: Ingredients listed on restricted chemical lists
EC/CAS
231-791-2/7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
EC/CAS
500-019-9/94-13-3
Name of the chemical
Propylparaben; propyl 4-hydroxybenzoate
Concentration
N/A
EC/CAS
9005-65-6
Name of the chemical
polyethyleneglycol sorbitan monooleate
Concentration
N/A
EC/CAS
202-785-7/8006-90-4
Name of the chemical
Mentha piperita oil (40)
Concentration
N/A
EC/CAS
99-76-3
Name of the chemical
4-hydroxybenzoic acid, methyl ester
Concentration
N/A
EC/CAS
202-307-7
Name of the chemical
Propylparaben; propyl 4-hydroxybenzoate
Concentration
N/A
General Information
Version
4
Revision date
2025-07-26
Product name
Medroxyprogesterone Acetate Oral Suspension
Product name
Medroxyprogesterone Acetate Oral Suspension
Identification on the label/Trade name
FARLUTAL; PROVERA
Chemical name
Mixture
1.2.1 Relevant identified uses
Pharmaceutical product
Emergency telephone
1-800-424-9300, +1-703-527-3887, +61 2 9037 2994
Icons in SDS
Company Information
company name
Pfizer Inc
e-mail address of the competent person responsible for the Safety Data Sheet
pfizer-MSDS@pfizer.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H351, H360FD, H380, H402, H412, H430
Hazard statements
Code
Statements
H351
Suspected of causing cancer
Section 2
SECTION 2: Hazards identification
OSHA Classification of the substance or mixture Carcinogenicity Category 2 - (H351) Reproductive toxicity Category 1A - (H360FD) Endocrine disruption for human health Category 1 - (H380) Hazardous to the aquatic environment - acute Category 3 - (H402) Hazardous to the aquatic environment - chronic Category 3 - (H412) Endocrine disruption for the environment Category 1 - (H430)
2.3 Other hazards
Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).
Signal word
Danger
Hazard statements
H351 - Suspected of causing cancer H360FD - May damage fertility. May damage the unborn child EUH380 - May cause endocrine disruption in humans H412 - Harmful to aquatic life with long lasting effects EUH430 - May cause endocrine disruption in the environment
Precautionary statements
P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P263 - Avoid contact during pregnancy/while nursing P273 - Avoid release to the environment P280 - Wear protective gloves and protective clothing P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable
PBT Substances
& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information Chemical name Contains a known or suspected endocrine disruptor.
2.1 Classification of the substance or mixture
Carcinogenicity Category 2 - (H351) Reproductive toxicity Category 1A - (H360FD) Endocrine disruption for human health Category 1 - (H380) Hazardous to the aquatic environment - acute Category 3 - (H402) Hazardous to the aquatic environment - chronic Category 3 - (H412) Endocrine disruption for the environment Category 1 - (H430) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable
