STERILE WATER- water injection, solution

Sterile Water by

Drug Labeling and Warnings

Sterile Water by is a Prescription medication manufactured, distributed, or labeled by ICU Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

    1000 mL

    NDC: 0990-7990-09

    STERILE WATER
    for Injection, USP

    DO NOT GIVE INTRAVENOUSLY.
    FOR DRUG DILUENT USE ONLY.

    CONTAINS NO ANTIMICROBIAL OR OTHER
    SUBSTANCE.

    ADMIXTURES SHOULD BE USED PROMPTLY
    WITH ADEQUATE PRECAUTIONS FOR
    MAINTAINING STERILITY.

    WARNINGS: NOT ISOTONIC.
    HEMOLYTIC.

    ADDITIVES MAY BE INCOMPATIBLE.
    CONSULTATION WITH A PHARMACIST IS
    RECOMMENDED. WHEN INTRODUCING
    ADDITIVES, USE ASEPTIC TECHNIQUE,
    MIX THOROUGHLY AND DO NOT STORE.

    SINGLE-DOSE CONTAINER. FOR INTRAVENOUS USE. DO
    NOT GIVE INTRAVENOUSLY UNLESS RENDERED NEARLY
    ISOTONIC. USUAL DOSAGE: SEE INSERT. STERILE,
    NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR
    AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN
    SERIES CONNECTIONS. pH 5.5 (5.0 to 7.0)

    RX ONLY

    3
    V
    CONTAINS DEHP

    icumedical

    IM-4423

    ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

    PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap

    2
    HDPE

    TO OPEN TEAR AT NOTCH

    DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
    THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
    IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
    RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE
    HEAT. PROTECT FROM FREEZING. SEE INSERT.
    98-4321-R14-3/98

    PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap
  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    water injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0990-7990
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1000 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0990-7990-0912 in 1 CASE10/01/2019
    11 in 1 POUCH
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01823310/01/2019
    Labeler - ICU Medical Inc. (118380146)

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