Tropicamide Ophthalmic Solution USP, 0.5%

Contains

Tropicamide 1508-75-4 NE 0.5 Boric Acid 10043-35-3 NE NE 1 Purified Water 7732-18-5 NE 1 Ingredients <1% - Edetate Disodium, Hydrochloric Acid, Benzalkonium Chloride 3. HAZARDS IDENTIFICATION ************************************************************************************************* EMERGENCY OVERVIEW Plastic bottle in a cardboard box. Clear, colorless and odorless, aqueous solution. Do not engage in hazardous activity while under the influence. May cause temporary light sensitivity. Avoid mouth and skin contact. Toxic by ingestion and skin contact. ************************************************************************************************* POTENTIAL HEALTH HAZARDS Carcinogenicity: (NTP) No (IARC) No (OSHA) No Eye: May cause irritation and hypersensitivity (anaphylactic) in some individuals. May cause temporary light sensitivity and increased intraocular pressure. Overdosage (systemic toxicity) is manifested by headache, blurred vision, a rapid and irregular pulse, psychotic reactions, unusual drowsiness and dry mouth. Severe reactions are manifested by low blood pressure (hypotension) with progressive respiratory depression. The main symptoms are drowsiness leading to coma. Once the drug is withdrawn, the mechanism of overdosage is self limiting. Skin: May cause irritation and hypersensitivity in some individuals. Toxic systemic effects may be induced by skin contact. Ingestion: May cause irritation, vomiting, diarrhea and hypersensitivity in some individuals. Ingestion of tropicamide can induce systemic toxicity effects. Inhalation: May cause irritation and hypersensitivity in some individuals. Chronic Effects: May cause irritation. May cause hypersensitivity. Severe reactions are manifested by hypotension with progressive respiratory depression. Target Organs: Eyes, central nervous system, respiratory and digestive tract. Medical Conditions Aggravated by Long Term Exposure Hypersensitivity to any of the components of the product. Animal reproduction studies have not been performed with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to pregnant woman only if clearly needed. Tropicamide is contraindicated in cases of primary and narrow angle glaucoma or anatomical narrow angles.