Procainamide Hydrochloride Injection, USP, Pronestyl

Sagent Pharmaceuticals

Revision date : 2025-07-23

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GHS07
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

<1%

EC/CAS

7681-57-4

Name of the chemical

Sodium metabisulfite

Concentration

<1%

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

N/A

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Version

2.0

Revision date

2025-07-23

Product name

Procainamide Hydrochloride Injection, USP, Pronestyl

Chemical name

Benzamide

1.2.1 Relevant identified uses

Group 1A cardiac antiarrhythmic drug

Icons in SDS

GHS07 M004 M009 M011 M017

Company Information

company name

Sagent Pharmaceuticals

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H315, H317, H319, H334, H335

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Acute toxicity - oral 4 Skin irritation 2 Eye irritation 2A Specific target organ toxicity (single exposure) 3

Signal word

Danger

Hazard statements

H315- Causes skin irritation H317 - May cause an allergic skin reaction. H319- Causes serious eye irritation. H335- May cause respiratory irritation. H334 - May cause allergy or asthma symptoms or breathing

Precautionary statements

P261 - Avoid breathing dust/fume/gas/mist/vapors/spray P264 - Wash thoroughly after handling. P270 - Do not eat, drink, or smoke when using this product. P271- Use only outdoors or in a well-ventilated area. P272 - Contaminated work clothing must not be allowed out of the workplace. P280 - Wear protective gloves/protective clothing/eye protection/face protection P284 - Wear respiratory protection P301+P312 If swallowed: Call a poison center/doctor if you feel unwell. P302- Harmful if swallowed. P330 Rinse mouth. P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing P305+P351+P338- If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P332+P313- If skin irritation occurs: Get medical advice/attention. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTRE or doctor/physician. P302+ P352 - IF ON SKIN: Wash with plenty of soap and water P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention P362 - Take off contaminated clothing and wash before reuse. P337+P313- If eye irritation persists: Get medical P403+P233- Store in a well-ventilated place. Keep container tightly closed. P405- Store locked up P501 - Dispose of contents/container in accordance with all local and national regulations (c) Description of Hazards N/A (d) Unknown Acute Toxicity: N/A –

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