Nitroglycerine Ointment

Allergan plc

Revision date : 2018-10-02

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GHS06 GHS08
Health risk rating 5
Safety risk rating 5
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

232-373-2/8009-03-8

Name of the chemical

Petrolatum

Concentration

7-13

Listed in

EC/CAS

200-240-8/55-63-0

Name of the chemical

Nitroglycerin; Propane-1,2,3-triyl trinitrate

Concentration

0.1-1

General Information

Version

11

Revision date

2018-10-02

Product name

Nitroglycerine Ointment

Product Synonyms

Rectiv

1.2.1 Relevant identified uses

Vasodilator indicated for the treatment of moderate to severe pain associated with chronic

Manufacturer Name

Allergan plc

Emergency telephone

1-800-424-9300, +1-703-741-5970

Icons in SDS

GHS06 GHS08

Company Information

company name

Allergan plc

e-mail address of the competent person responsible for the Safety Data Sheet

SDS@Allergan.com

GHS Information

Signal word

Danger

Section 2

SECTION 2: Hazards identification

OSHA Hazards Classification

2.2 Label elements

Emergency Overview Danger

Hazard statements

H302 - Harmful if swallowed H311 - Toxic in contact with skin H350 - May cause cancer Appearance Ointment Chemical Name Nitroglycerin Physical state Solid Odor No information available Symptoms In therapeutic use headache which may be severe and persistent may occur immediately after administration. Vertigo, dizziness, weakness, palpitation, flushing, rash, exfoliative dermatitis and adverse vascular effects have been reported. Allergic reactions to organic nitrates are extremely rare, but they dooccur and are manifested by nausea, vomiting, weakness, excessive sweating, pallor, and collapse. Limited evidence of harm to fetus during pregnancy, based on animal data. More serious adverse effects are the result of Nitroglycerin’s capacity to induce vasodilatation, venous pooling, reduced cardiac output,and hypotension. Manifested symptoms have included increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever, vertigo, palpitations, rapid heart beat, visual disturbances, nausea and vomiting (possibly with colic and even bloody diarrhea), fainting (especially in the upright posture), difficulty breathing,later followed by labored breathing, excessive sweating, with the skin either flushed or cold and clammy, heart block and abnormal slow heart beat, paralysis, coma, seizures, and death. Methemoglobinemia has been rarely reported in association with organic nitrates. Methemoglobinemia is a condition where the blood cannot absorb sufficient oxygen and tissues become hypoxic. Chemical Name Nitroglycerin

Medical Conditions Generally Aggravated by Exposure

Individuals with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known sensitivity or hypersensitivity to nitroglycerin or its ingredients, or other nitrates or nitrites.Concomitant use with phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil citrate (VIAGRA†) since it has been shown to potentiate the hypotensive effects of nitrates.

Precautionary statements

P264 - Wash face, hands and any exposed skin thoroughly after handling P270 - Do not eat, drink or smoke when using this product P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell P330 - Rinse mouth P312 - Call a POISON CENTER or doctor if you feel unwell P361 - Remove/Take off immediately all contaminated clothing P363 - Wash contaminated clothing before reuse P302 + P352 - IF ON SKIN Wash with plenty of soap and water P322 - Specific measures (see supplemental first aid instructions on this label) P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant P280 - Wear protective gloves/protective clothing/eye protection/face protection

Further information

Unknown Acute Toxicity 1.6% of the mixture consists of ingredient(s) of unknown toxicity

2.1 Classification of the substance or mixture

OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Acute toxicity - Oral Category 4 Acute toxicity - Dermal Category 3 Carcinogenicity

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