ProAir HFA Aerosol, Metered (and with dose counter)

TEVA

Revision date : 2012-07-20

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GHS07
Health risk rating 4
Safety risk rating 4
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-578-6/64-17-5

Name of the chemical

Ethanol

Concentration

N/A

EC/CAS

811-97-2

Name of the chemical

1,1,1,2-Tetrafluoroethane

Concentration

212-327-

General Information

Revision date

2012-07-20

Product name

ProAir HFA Aerosol, Metered (and with dose counter)

Emergency telephone

1-800/424-9300, 01-703-527-3887

Icons in SDS

Company Information

company name

TEVA

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

bernadette.pogozelski@tevapharm.com

GHS Information

Signal word

Warning

Section 2

SECTION 2: Hazards identification

1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC)

Product definition

This product consists of a white, crystalline powder solubilized in ethanol, and delivered in a pressurized container by a non-flammable gas. Health Hazards: Inhalation of high quantity may be harmful. Skin and eye contact may cause irritation. Prolonged skin contact may cause defatting of the skin. Ingestion is not a likely route of exposure. The most common adverse effects from therapeutic use of this product have been headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. Deliberate ‘sniffing’ of this product can be harmful, causing headache, nausea, dizziness and weakness and other adverse central nervous system effects and adverse effects on the heart. In therapeutic use, the most common adverse effect has been nasal irritation, prolonged sneezing and burning sensation in the nose. Severe allergic reaction, including anaphylaxis has been reported. The active ingredient is a suspect reproductive toxin. See Section 11 (Toxicological Information) for more information on possible therapeutic use effects. If a release of many containers of this product occurs at the same time, an oxygen-deficient environment can occur, resulting in a hazard of asphyxiation. If containers are heated or punctured, rupture may occur, and may cause injury. Flammability Hazards: This product is not normally flammable. May burn if highly heated or if subjected to direct flame. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (carbon, nitrogen and sulfur oxides, hydrogen fluoride, carbonyl fluoride, vinylidene fluoride, hydrogen chloride, and carbon oxides). Reactivity Hazards This product is not reactive.

Environmental hazards

Because of the potential global warming and ozone depletion effects caused by the 1,1,1,2-Tetrafluoroethane component, this product should be released to the environment only as a last resort. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding. Persons responding to an emergency such as a fire that involves this product must take precautions to avoid potential injury from containers that rupture.

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