Label: LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution

  • NDC Code(s): 0338-9596-01, 0338-9596-24, 0338-9600-01, 0338-9600-12
  • Packager: Baxter Healthcare Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 2, 2024

If you are a consumer or patient please visit this version.

  • Health Care Professional Letter

    DHCP Letter 1 of 17
    DHCP Letter 2 of 17
    DHCP Letter 3 of 17
    DHCP Letter 4 of 17

    Reportin Adverse Events or Product Quality Issues

    To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, or by regulary mail or by fax:

    Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
    Regular mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178)

    To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter – Product Feedback Portal (https://productfeedback.baxter.com/).

    Please refer to the FDA-approved prescribing information for each drug product as follows:

    5% Dextrose Injection, USP (click DailyMed - DEXTROSE- dextrose monohydrate injection, solution)
    0.9% Sodium Chloride Injection, USP (click DailyMed - SODIUM CHLORIDE injection, solution)
    Lactated Ringers Injection, USP (click DailyMed - LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution)
    DHCP Letter 5 of 17
    Plasma-Lyte Injection, USP (click DailyMed - PLASMA-LYTE A- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution)
    DHCP Letter 6 of 17
    DHCP Letter 7 of 17
    DHCP Letter 8 of 17
    DHCP Letter 9 of 17
    DHCP Letter 10 of 17
    DHCP Letter 11 of 17
    DHCP Letter 12 of 17
    DHCP Letter 13 of 17
    DHCP Letter 14 of 17
    DHCP Letter 15 of 17
    DHCP Letter 16 of 17
    DHCP Letter 17 of 17
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Container Label NDC 0338-9600-01

    Container Label

    JB2324
    1000 mL
    DIN 00061085

    Lactated Ringer’s
    Injection USP

    Lactate de Ringer
    USP, Injectable

    Lactated Ringer

    Lactate de Ringer

    APPROX mmol/L Na – 130 K – 4 Ca – 1.4
    CI – 109 LACTATE – 28 mOsmol/L – 272 pH 6.5

    INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT
    RETABLISSEMENT HYDRO-ELECTROLYTIQUE PAR INJECTION
    INTRAVENIEUSE

    PER 100 mL SODIUM CHLORIDE USP – 600 mg / SODIUM LACTATE – 310
    mg / POTASSIUM CHLORIDE USP – 30 mg / CALCIUM CHLORIDE
    DIHYDRATE USP – 20 mg / WATER FOR INJECTION USP – qs

    PAR 100 mL CHLORURE DE SODIUM USP – 600 mg / LACTATE DE SO-
    DIUM – 310 mg/ CHLORURE DE POTASSIUM USP – 30 mg / DIHYDRATE DE
    CHLORURE DE CALCIUM USP – 20 mg / EAU POUR INJECTION USP – qs

    CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE
    AND INSPECT BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE
    TREATEMENT OF LACTIC ACIDOSIS / MUST NOT BE USED IN SERIES
    CONNECTIONS / DO NOT ADMINSTER SIMULTANEOUSLY WITH BLOOD
    STORE AT 15°C TO 25°C

    ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER
    ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS
    LE TRAITEMENT DE L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE
    EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG
    GARDER ENTRE 15°C ET 25°C

    NONPYROGENIC / STERILE / APYROGENE

    VIAFLEX PVC CONTAINER / CONTENANT DE PVC

    BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
    BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER
    INTERNATIONAL INC

    Baxter Logo
    Baxter Corporation
    Mississauga ON L5N 0C2

    No Latex Label

    88-70-20-487

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    Container Label NDC 0338-9596-01

    Container Label

    JB2323
    500 mL
    DIN 00061085

    Lactated Ringer’s Injection
    USP

    Lactate de Ringer USP,
    Injectable

    Lactated Ringer

    Lactate de Ringer

    APPROX mmol/L Na – 130 K – 4 Ca – 1.4 CI
    109 LACTATE – 28 mOsmol/L – 272 pH 6.5

    INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT / RETABLISSE-
    MENT HYDRO-ELECTROLYTIQUE PAR INJECTION INTRAVENIEUSE

    PER100 mL SODIUM CHLORIDE USP – 600mg / SODIUM LACTATE – 310mb / PO-
    TASSIUM CHLORIDE USP – 30mg / CALCIUM CHLORIDE DIHYDRATE USP – 20mg /
    WATER FOR INJECTION USP – qs

    PAR100 mL CHLORURE DE SODIUM USP – 600mg / LACTATE DE SODIUM –
    310mg/ CHLORURE DE POTASSIUM USP – 30mg / DIHYDRATE DECHLORURE DE
    CALCIUM USP – 20mg / EAU POUR INJECTION USP – qs

    CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT
    BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE TREATEMENT OF LACTIC
    ACIDOSIS / MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT ADMINSTER
    SIMULTANEOUSLY WITH BLOOD STORE AT 15°C TO 25°C

    ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECT-
    ER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS LE TRAITEMENT DE
    L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER
    SIMULTANEMENT AVEC LE SANG GARDER ENTRE 15°C ET 25°C

    NONPYROGENIC / STERILE / APYROGENE

    VIAFLEX PVC CONTAINER / CONTENANT DE PVC

    BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
    BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER
    INTERNATIONAL INC

    Baxter Logo
    Baxter Corporation
    Mississauga ON L5N 0C2

    No Latex Label

    07-25-77-062

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  • INGREDIENTS AND APPEARANCE
    LACTATED RINGERS 
    sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9600
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9600-1212 in 1 CARTON11/06/2024
    1NDC:0338-9600-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage11/06/2024
    LACTATED RINGERS 
    sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9596
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9596-2424 in 1 CARTON11/06/2024
    1NDC:0338-9596-01500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage11/06/2024
    Labeler - Baxter Healthcare Company (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Corporation205087968ANALYSIS(0338-9600, 0338-9596) , LABEL(0338-9600, 0338-9596) , MANUFACTURE(0338-9600, 0338-9596) , STERILIZE(0338-9600, 0338-9596) , PACK(0338-9600, 0338-9596)