STERILE WATER

HOW SUPPLIED: Sterile Water for Injection, USP NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25 NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25 NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25 NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN3005 Rev. 1/09; PRINCIPAL DISPLAY PANEL - 5 mL Contain NDC 0517-3005-01 STERILE WATER FOR INJECTION, USP 5 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3005-25 25 x 5 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 5 mL container label Carton; PRINCIPAL DISPLAY PANEL - 10 mL Container NDC 0517-3010-01 STERILE WATER FOR INJECTION, USP 10 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3010-25 25 x 10 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 10 mL container label Carton Labeling - 10 mL; PRINCIPAL DISPLAY PANEL - 20 mL Container NDC 0517-3020-01 STERILE WATER FOR INJECTION, USP 20 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3020-25 25 x 20 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 5/18 20 mL container label Carton Labeling - 20 mL; Serialization Label - 5 mL Serialization Label - 5 mL; Serialization Label - 10 mL Serialization Label - 10 mL; Serialization Label - 20 mL Serialization Label - 20 mL

• HOW SUPPLIED: Sterile Water for Injection, USP NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25 NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25 NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25 NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN3005 Rev. 1/09
• PRINCIPAL DISPLAY PANEL - 5 mL Contain NDC 0517-3005-01 STERILE WATER FOR INJECTION, USP 5 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3005-25 25 x 5 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 5 mL container label Carton
• PRINCIPAL DISPLAY PANEL - 10 mL Container NDC 0517-3010-01 STERILE WATER FOR INJECTION, USP 10 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3010-25 25 x 10 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 10 mL container label Carton Labeling - 10 mL
• PRINCIPAL DISPLAY PANEL - 20 mL Container NDC 0517-3020-01 STERILE WATER FOR INJECTION, USP 20 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3020-25 25 x 20 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 5/18 20 mL container label Carton Labeling - 20 mL
• Serialization Label - 5 mL Serialization Label - 5 mL
• Serialization Label - 10 mL Serialization Label - 10 mL
• Serialization Label - 20 mL Serialization Label - 20 mL