Betamethasone Dipropionate Ointment 0.05%

SECTION 2: Hazards identification

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

Product definition

This product is a translucent, white to off-white ointment with a mild petroleum jelly odor. 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 and mutagenic effects, based on animal data. Flammability Hazards: If heated to high temperatures for a prolonged period, the water in this product can evaporate off and the residue may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon, sodium, nitrogen and sulfur oxides and hydrogen fluoride). Reactivity Hazards This product is not reactive.

Environmental hazards

This product has not been tested for environmental effects, however, all release to the environment should be avoided. Emergency Considerations: Emergency responders should wear appropriate protection for situation to which they respond.