Note: Ingredients listed on restricted chemical lists
EC/CAS
9005-25-8
Name of the chemical
Starch
Concentration
N/A
EC/CAS
209-150-3/9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
EC/CAS
232-679-6
Name of the chemical
Starch
Concentration
N/A
General Information
Version
4
Revision date
2025-06-16
Product name
Norethisterone/Ethinyl Estradiol Tablets
Product name
Norethisterone/Ethinyl Estradiol Tablets
Identification on the label/Trade name
BREVINOR; SYNPHASE; SYNPHASIC; SYNPHASEC; CONCEPLAN M; NORIMIN
Chemical name
Mixture
1.2.1 Relevant identified uses
Pharmaceutical product used as oral contraceptive
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, H402, H412
Hazard statements
Code
Statements
H351
Suspected of causing cancer
Section 2
SECTION 2: Hazards identification
OSHA Classification of the substance or mixture
2.3 Other hazards
Not applicable (HNOC) Causes mild skin irritation. 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 H412 - Harmful to aquatic life with long lasting effects
Precautionary statements
P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood 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 95.43 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 99.43 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 99.43 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist). 99.43 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (gas). 99.43 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (vapor). Unknown aquatic toxicity Contains 0 % of components with unknown hazards to the aquatic environment.
PBT Substances
& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.
2.1 Classification of the substance or mixture
GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Carcinogenicity Category 2 - (H351) Reproductive toxicity Category 1A - (H360FD) Hazardous to the aquatic environment - acute Category 3 - (H402) Hazardous to the aquatic environment - chronic Category 3 - (H412) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable