ANDRODERM

SECTION 2: Hazards identification

Signal word

Not Applicable

Hazard statements

Not Applicable EU LABELING AND CLASSIFICATION 67/548/EEC: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. Not Applicable Not Applicable

Precautionary statements

Not Applicable See Section 16 for full EU classification information of product and components and full text of hazard and precautionary statements. EMERGENCY OVERVIEW

Product definition

This product is a translucent laminate patch with adhesive on one side, packaged in a foil-backed pouch. The raw chemical ingredients are mixed with the solution, which is then applied to the patch. Although the raw adhesive contains a toluene, heptane, isopropanol, ethyl acetate and vinyl acetate, these volatile compounds are removed in the manufacturing process and only trace amounts remain in the final product.

Health hazards

The chief health hazard associated with overexposures during normal use and handling is the potential for irritation of contaminated skin. Testosterone (the active component in this product) is a possible reproductive toxin and potential human carcinogen. Individuals who have had allergic reactions to prescription as well as to over-the-counter products containing androgens, anabolic steroids, or estrogens may experience allergic reactions to this product. Therapeutic use of Testosterone can lead to adverse symptoms on the cardiac system, liver kidneys, central nervous system, and blood. Reactivity Hazards: This product is not reactive. Flammability Hazards: If heated to high temperatures for a prolonged period, the product may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon monoxide and carbon dioxide).

Environmental hazards

Large quantities released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for situation to which they respond.