Label: LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, calcium chloride irrigant

  • NDC Code(s): 0338-0114-04
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 12, 2012

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  • DESCRIPTION

    Lactated Ringer’s Irrigation

    Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

  • INDICATIONS AND USAGE

    Isotonic solution for irrigation only. Not for injection.

  • DOSAGE AND ADMINISTRATION

    As directed by a physician.

    Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

  • HOW SUPPLIED

    Recommended storage: Room temperature (25°C). Avoid excessive heat.

  • PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

    Lactated Ringer's Irrigation Representative Container Label

    Container Label

    Container Label

    2F7154
    NDC 0338-0114-04

    1000 mL

    Baxter Logo

    Not for Injection

    Lactated Ringer's
    Irrigation

    Each 100 mL contains: 600 mg Sodium
    Chloride, USP, 310 mg Sodium Lactate, 30
    mg Potassium Chloride, USP, 20 mg Calcium
    Chloride, USP. No antimicrobial agent has been
    added. pH 6.5 (6.0 to 7.5). Osmolarity 273
    mOsmol/L (calc.). Sterile, nonpyrogenic. Pour
    Bottle. Isotonic solution for irrigation only.
    Dosage and Administration: As directed by a
    physician. Cautions: Warm in oven to not more
    than 50°C for a maximum of 60 days. Discard
    after 60 days of warming. Do not use unless
    solution is clear and seal is intact. Discard
    unused portion. Rx only. Recommended
    storage: Room temperature (25°C). Avoid
    excessive heat.

    PL 325 plastic

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Made in USA

    LOT
    EXP
    FPO
    (91)0709000249
    Bar Code

    07-09-00-0249

    Bar Code Position Only*
    303380114047

    Lactated Ringer's Irrigation Representative Carton Label

    Carton Label

    Carton Label

    Lactated Ringer's
    Irrigation
    Pour Bottle

    1000 mL

    Qty
    12

    NDC 0338-0114-04

    2F7154

    EXP

    LOT#

    (01)50303380114042(17)080630(10)G012345

    07-06-47-995

  • INGREDIENTS AND APPEARANCE
    LACTATED RINGERS 
    sodium chloride, sodium lactate, potassium chloride, calcium chloride irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0114
    Route of AdministrationIRRIGATION
    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) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) 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:0338-0114-0412 in 1 CARTON02/19/1982
    11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01849402/19/1982
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation001728059ANALYSIS(0338-0114) , MANUFACTURE(0338-0114) , LABEL(0338-0114) , PACK(0338-0114) , STERILIZE(0338-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764API MANUFACTURE(0338-0114)