Betamethasone Valerate Lotion, USP 0.1%

SECTION 2: Hazards identification

1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC)

Product definition

This product is a slightly turbid viscous liquid.

Health hazards

The chief health hazard associated with exposure during normal use and handling is the potential for mild irritation of contaminated skin. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, high blood sugar, and excretion of glucose into the urine have been reported. Rarely, immediate hypersensitivity reactions or contact dermatitis may occur from therapeutic use in sensitive individuals. Use can lead to slow wound-healing and a weakened immune system. Long-term use may result in bone density loss. There is limited evidence of harm to the fetus during pregnancy, based on animal data. These effects may be possible as a result of workplace exposure. See Section 11 (Toxicological Information) for information on other known from therapeutic use. Flammability Hazards This product is flammable. It is readily ignited under ambient conditions. Vapors from the Isopropyl Alcohol component of this product are heavier than air and may travel to a source of ignition and flashback to a leak or open container. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon oxides, and hydrogen fluoride). Reactivity Hazards This product is not reactive.

Environmental hazards

This product has not been tested for

Environmental effects

Emergency Considerations Emergency responders should wear appropriate protection for situations to which they respond.