Bepotastine Besilate Ophthalmic Solution 1.5%

Somerset Therapeutics, LLC.

Revision date : 2024-09-06

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

>90%

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

To adjust to pH NA

EC/CAS

63449-41-2

Name of the chemical

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

Concentration

0.005%

General Information

Revision date

2024-09-06

Product name

Bepotastine Besilate Ophthalmic Solution 1.5%

1.2.1 Relevant identified uses

Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis

1.2.2. Uses advised against

Refer to product prescribing information. Refer to the product insert and/or prescribing information for restrictions on use and contraindications

Icons in SDS

M004 M009 M010 M011 M017

Company Information

company name

Somerset Therapeutics, LLC.

GHS Information

Signal word

WARNING

Hazard Codes

Hazard statements (CLP)

H303, H320

Hazard statements

Code

Statements

H303

May be harmful if swallowed

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 Acute Toxicity Oral 5 Eye Mild Irritation 2B

2.2 Label elements

UN GHS WARNING

Hazard statements

Causes eye irritation May be harmful if swallowed

Prevention

Use only in accordance with label instructions and supplied prescribing information Wash thoroughly after handling.

Response

IF SWALLOWED Immediately call a POISON CENTER or doctor/physician If eye irritation persists: Get medical advice/attention. IF ON SKIN: Wash with plenty of soap and water. Storage/Disposal Keep tightly closed. Store at room temperature 15-25ºC (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

UN GHS No data available

2.1 Classification of the substance or mixture

UN GHS Acute Toxicity Oral 5 Eye Mild Irritation 2B

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