XARTEMIS

SECTION 2: Hazards identification

OSHA identification

Physical hazards

Physical hazards Not classified.

Health hazards

Health hazards Acute toxicity, oral Category 3 Sensitization, respiratory Category 1 Sensitization, skin Category 1 Specific target organ toxicity, single exposure Category 2 (liver, kidneys) Specific target organ toxicity, single exposure Category 3 narcotic effects Specific target organ toxicity, repeated Category 2 (liver) exposure

Environmental hazards

Environmental hazards Not classified. OSHA OSHA defined defined defined hazards Not classified.

Contains

ACETAMINOPHEN, HYDROXYPROPYL CELLULOSE, OXYCODONE HYDROCHLORIDE, POLYETHYLENE OXIDE Label

2.2 Label elements

elements

Signal word

Signal word Danger

Hazard statements

Hazard statement Narcotic. Toxic if swallowed. May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an allergic skin reaction. May cause damage to organs (liver, kidneys). May cause drowsiness or dizziness. May cause damage to organs (liver) through prolonged or repeated exposure. Precautionary

Prevention

Do not breathe dust/fume. Use only outdoors or in a well-ventilated area. In case of inadequate ventilation wear respiratory protection. Do not eat, drink or smoke when using this product. Wear protective gloves. Wash thoroughly after handling. Contaminated work clothing must not be allowed out of the workplace.

Response

If swallowed Immediately call a poison center/doctor. Rinse mouth. If on skin Wash with plenty of water. If skin irritation or rash occurs Get medical advice/attention. If inhaled Remove person to fresh air and keep comfortable for breathing. If experiencing respiratory symptoms: Call a poison center/doctor. Get medical advice/attention if you feel unwell. Wash contaminated clothing before reuse.

Storage

Store in a well-ventilated place. Keep container tightly closed. Store locked up.

Disposal

Dispose of contents/container in accordance with local/regional/national/international regulations. Hazard(s) Hazard(s) not not not otherwise otherwise None known.

Classified (HNOC)

classified (HNOC)

Additional information

Supplemental information The hazard warnings associated with this product are based on the individual ingredients included in the finished dosage form of the pharmaceutical product. The supplied package insert (approved labeling) provides the necessary drug safety information. As per 29 CFR 1910.1200(b)(5)(iii), any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and regulations issued under that Act, when they are subject to the labeling requirements under that Act by the Food and Drug Administration are exempted from the requirements of the Hazard Communication Standard. All Mallinckrodt finished products are labeled in compliance with the requirements of the Food and Drug Administration (FDA) and must be used in the prescribed manner. Each package of the finished pharmaceutical product is supplied with a package insert (approved labeling) which provides necessary drug safety information. 3. 3. 3. 3. Composition/information