Note: Ingredients listed on restricted chemical lists
EC/CAS
205-351-5/139-07-1
Name of the chemical
Benzododecinium chloride
Concentration
<0.005%
EC/CAS
233-139-2/10043-35-3
Name of the chemical
Borsäure Borsäure
Concentration
<1%
EC/CAS
200-289-5/56-81-5
Name of the chemical
glycerol
Concentration
99.7% <1%
EC/CAS
200-338-0/57-55-6
Name of the chemical
1,2-propanediol
Concentration
<1%
EC/CAS
231-791-2/7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
<0.1 %
EC/CAS
215-185-5/1310-73-2
Name of the chemical
sodium hydroxide
Concentration
N/A
General Information
Revision date
2023-11-16
Product name
Loteprednol Etabonate Ophthalmic Gel, 0.5%
Product Synonyms
chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3- oxoandrosta-1,4-diene-17β-carboxylate
1.2.1 Relevant identified uses
Corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery
Manufacturer Name
Ophtapharm AG
Emergency telephone
+1855-473-6847
Icons in SDS
Company Information
company name
Ophtapharm AG
e-mail address of the competent person responsible for the Safety Data Sheet
quality@sentiss.ch
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H361
Hazard statements
Code
Statements
H361
Suspected of damaging fertility or the unborn child
Section 2
SECTION 2: Hazards identification
UN GHS : According to: UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Classification of the substance or mixture UN GHS
Health hazards
Reproductive Toxicity Category 2
Signal word
Warning
Hazard statements
Suspected of damaging fertility or the unborn child
Precautionary statements
Do not handle until all safety precautions have been read and understood. Wash thoroughly after handling. Use personal protective equipment as required. IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs: Get medical advice/attention.
Storage
Disposal : Keep tightly closed. Store at room temperature 15-25 ºC (59-77ºF), to maintain product integrity. Use before date marked on carton and/or container. Dispose of content and/or container in accordance with local, regional, national, and/or international regulations.
2.3 Other hazards
No data available
2.1 Classification of the substance or mixture
Classification of the substance or mixture UN GHS Health Hazards : Reproductive Toxicity Category 2 Symbol(s) : Signal Word : Warning Hazard Statement(s) : Suspected of damaging fertility or the unborn child
