Note: Ingredients listed on restricted chemical lists
EC/CAS
232-293-8/8001-79-4
Name of the chemical
castor oil
Concentration
N/A
EC/CAS
500-019-9/9005-65-6
Name of the chemical
polyethyleneglycol sorbitan monooleate
Concentration
N/A
EC/CAS
231-791-2/7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
General Information
Revision date
2015-08-12
Product name
Cyclosporine OphthalmicEmulsion 0.05%
Product Synonyms
RESTASIS
Chemical name
Cyclo{[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methyglycyl-N-methyl-L-leucyl-L-valy-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valy}
supplier name
U.S
Emergency telephone
1-800-424-9300, +1-703-527-3887
Icons in SDS
Company Information
company name
U.S
e-mail address of the competent person responsible for the Safety Data Sheet
SafetyDataSheets@Actavis.com
GHS Information
Signal word
Not Applicable
Section 2
SECTION 2: Hazards identification
Signal word
Not Applicable
Hazard statements
Not Applicable EU LABELING AND CLASSIFICATION 67/548/EEC: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. Not Applicable Not Applicable
Precautionary statements
Not Applicable See Section 16 for full EU classification information of product and components and full text of hazard and precautionary statements. EMERGENCY OVERVIEW
Product definition
This product is a colorless to light-yellow, odorless emulsion
Health hazards
This product is a carcinogenic immuno-suppresive agent. This product can cause cancer and adverse reproductive effects. The chief health hazard associated with exposure during normal occupational handling is the potential for irritation of contaminated skin. Individuals who have had allergic reactions to products containing the active ingredient, Cyclosporine (or any other components of this product) may experience allergic reactions to this product. Flammability Hazards: When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon oxides and nitrogen oxides). Reactivity Hazards: This product is not reactive.
Environmental hazards
Large quantities released to the environment may have an adverse effect Emergency Considerations: Emergency responders should wear appropriate protection for situation to which they respond.
