Note: Ingredients listed on restricted chemical lists
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
General Information
Revision date
2022-01-18
Product name
Esomeprazole Tablets
Product Synonyms
NEXIUM 24HR TABLET * ESOMEPRAZOLE MAGNESIUM (DELAYED RELEASE TABLETS)
Icons in SDS
Company Information
company name
GlaxoSmithKline UK
e-mail address of the competent person responsible for the Safety Data Sheet
msds@gsk.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H317
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
2.1 Classification of the substance or mixture
The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.
EU Classification
Regulation (EC) No 1272/2008 as amended
Health hazards
Skin sensitisation Category 1 H317 - May cause an allergic skin reaction. Hazard summary May cause an allergic skin reaction. Prolonged exposure may cause chronic effects. Occupational exposure to the substance or mixture may cause adverse health effects.
2.2 Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains
ESOMEPRAZOLE MAGNESIUM
Signal word
Warning
Hazard statements
H317 May cause an allergic skin reaction.
Prevention
P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves.
Response
P321 Specific treatment (see on this label). P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P362 + P364 Take off contaminated clothing and wash it before reuse.
Storage
Not available.
Disposal
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
Supplemental label elements
81,39 % of the mixture consists of component(s) of unknown acute oral toxicity. 93,04 % of the mixture consists of component(s) of unknown acute dermal toxicity. 95,34 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 88,69 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.
2.3 Other hazards
This mixture does not contain substances assessed to be vPvB / PBT according to Regulation (EC) No 1907/2006, Annex XIII. The product does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
