ESTRACE (Estradiol Vaginal Cream, USP, 0.01%)

SECTION 2: Hazards identification

Product definition

This product is a white to off-white cream supplied in tubes with an applicator

Health hazards

The chief health hazard associated with overexposures during normal use and handling is the potential for irritation of contaminated skin. In therapeutic use, the most common adverse effects reported include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss. May be absorbed through the skin. Chronic exposure may cause temporary impairment of fertility in both genders; interference with egg and sperm production. In men, exposure to female hormones has been associated with testicular atrophy, increased risk of prostate cancer, gynecomastia, loss of libido and potency. Can cause fetal harm in pregnancy, as an estrogen. Long-term therapeutic use can cause adverse effects on cardiovascular system with a greater risk for cigarette smokers. Limited evidence of carcinogenic effect; prolonged therapy poses a greater risk of cancer in post- menopausal women. Refer to Section 11 (Toxicological Information) for more information on potential health effects from therapeutic use. Reactivity Hazards: This product is not reactive. Flammability Hazards: This product may be combustible and ignite if exposure to high temperature or direct flame for a prolonged period. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon, sodium and nitrogen oxides).

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.