SPL Set ID: dd45cee3-9938-4dad-a5e1-1dd4baea85a9

Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8-3.4) Calculated Osmolarity: 42 mOsmol/liter The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Glacial Acetic Acid USP CH 3 COOH 60.05 0.25% Acetic Acid Irrigation USP is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. It contains no preservatives or added buffers. The solution is hypotonic. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP.