GABLOFEN

SECTION 2: Hazards identification

OSHA identification

Physical hazards

Physical hazards Not classified.

Health hazards

Health hazards Not classified.

Environmental hazards

Environmental hazards Not classified. OSHA OSHA defined defined defined hazards Not classified. *Hazards not stated here are "Not classified", "Not applicable" or "Classification not possible".

Contains

BACLOFEN, Saline Solution Label

2.2 Label elements

elements

Hazard pictograms

Hazard symbol None.

Signal word

Signal word None.

Hazard statements

Hazard statement The mixture does not meet the criteria for classification. Precautionary

Prevention

Observe good industrial hygiene practices.

Response

Wash hands after handling.

Storage

Store away from incompatible materials.

Disposal

Dispose of waste and residues in accordance with local authority requirements. 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