Prednisolone Acetate Ophthalmic Suspension USP 1%

Lupin Limited

Revision date : 2024-08-12

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7631-90-5

Name of the chemical

Sodium hydrogensulphite; Sodium bisulphite

Concentration

N/A

EC/CAS

63449-41-2

Name of the chemical

Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides

Concentration

N/A

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

9005-65-6

Name of the chemical

polyethyleneglycol sorbitan monooleate

Concentration

N/A

General Information

Revision date

2024-08-12

Product name

Prednisolone Acetate Ophthalmic Suspension USP 1%

1.2.1 Relevant identified uses

of the substance or Pharmaceutical mixture

Manufacturer Name

Lupin Limited

Icons in SDS

GHS08 M004 M009 M010 M011 M013 M017 M059

Company Information

company name

Lupin Limited

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H361, H362

Hazard statements

Code

Statements

H361

Suspected of damaging fertility or the unborn child

Section 2

SECTION 2: Hazards identification

Classification of the substance or mixture Carcinogenicity Reproductive toxicity Not suspected of being a human carcinogen Reproductive toxicity of Category-2 Identified Specific target organ toxicity - No data available repeated exposure Long-term (chronic) aquatic hazard No data available

Signal word

Danger

Hazard statements

May cause harm to breast-fed children. Suspected of damaging fertility or the unborn child.

Precautionary statements

IF ON SKIN: Wash with plenty of soap and water. If skin irritation occurs: Get medical advice/attention. Take off contaminated clothing and wash before reuse. If eye irritation persists: Get medical advice/attention. Do not handle until all safety precautions have been read and understood. Store locked up. Dispose of contents/ container to an approved waste disposal plant. Wear protective gloves/protective clothing/eye protection/face protection. Avoid contact during pregnancy/while nursing. Wash face, hands and any exposed skin thoroughly after handling. Do not eat, drink or smoke when using this product.

2.3 Other hazards

No data available.

2.1 Classification of the substance or mixture

Carcinogenicity Not suspected of being a human carcinogen. Reproductive toxicity Reproductive toxicity of Category-2 Identified. Specific target organ toxicity - No data available repeated exposure Long-term (chronic) aquatic hazard No data available

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