EXALGO

SECTION 2: Hazards identification

OSHA identification

Physical hazards

Physical hazards Not classified.

Health hazards

Health hazards Acute toxicity, oral Category 2 Acute toxicity, dermal Category 2 Sensitization, respiratory Category 1 Sensitization, skin Category 1 Reproductive toxicity Category 2 Specific target organ toxicity, single exposure Category 3 narcotic effects

Environmental hazards

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

Contains

HYDROMORPHONE HYDROCHLORIDE, POLYETHYLENE GLYCOL, TITANIUM DIOXIDE Label

2.2 Label elements

elements

Signal word

Signal word Danger

Hazard statements

Hazard statement Narcotic. Fatal if swallowed or in contact with skin. May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an allergic skin reaction. Suspected of damaging fertility or the unborn child. May cause drowsiness or dizziness. Precautionary

Prevention

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Avoid breathing dust. Use only outdoors or in a well-ventilated area. In case of inadequate ventilation wear respiratory protection. Do not get in eyes, on skin, or on clothing. Do not eat, drink or smoke when using this product. Wear protective gloves/protective clothing/eye protection/face protection. 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. Immediately call a poison center/doctor. 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. Call a poison center/doctor if you feel unwell. If exposed or concerned: Get medical advice/attention. Take off immediately all contaminated clothing and wash it 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