SPL Set ID: 3cfdeee0-ff14-4341-8396-b11c2a037c60

These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na + 154; Cl − 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.