CONDYLOX (PODOFILOX) GEL 0.5%

SECTION 2: Hazards identification

Product definition

This product is a clear, colorless gel with an alcohol odor supplied in tubes

Health hazards

The chief health hazard associated with overexposures during normal use and handling is the potential for irritation of contaminated skin. The active ingredient is toxic if swallowed and in contact with skin. Prolonged or chronic skin contact be harmful and cause systemic effects. In therapeutic use, the most common systemic adverse effect reported is headache. The most common adverse effects at the site of application include inflammation, redness, burning, skin erosion, pain, itching and bleeding. Less common adverse effects reported include peeling, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters. Therapeutic use of may also cause nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. If vapors or mists created from the gel are inhaled, irritation of the respiratory system can occur. Podofilox may cause harm to the fetus, based on animal data. Animal studies indicate mutagenic potential by causing chromosomal breaks in mouse in vivo micronucleus tests. Some components are suspect carcinogens. 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: The Gel is a Class 1B flammable liquid that is readily ignited under almost all conditions. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon, sodium and nitrogen oxides and acrolein).

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.