GABLOFEN

Physical hazards

Not classified

Health hazards

Not classified

Environmental hazards

Not Classified OSHA Defined Hazards: Not Classified

2.2 Label elements

Contains BACLOFEN, Saline Solution None

Hazard pictograms

None

Signal word

None

Hazard statements

The mixture does not meet the criteria for classification

Prevention

Observe good industrial hygiene practices

Response

Wash hands after handling

Storage

Store away from incompatible materials Dispose: Dispose of waste and residues in accordance with local authority requirements. (None known) Hazard(s) Not Otherwise Classified (HNOC): None Known

Additional 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 Piramal 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.