Label: TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

  • NDC Code(s): 0338-0190-04
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 21, 2014

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

  • DESCRIPTION

    Tis-U-Sol® Solution

    (Pentalyte Irrigation)

    Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25 mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0). Osmolarity 288 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

    Representative Container Label for Tis-U-Sol, NDC 0338-0190-04

    2F7144
    NDC 0338-0190-04

    1000 mL
    DIN 00800007

    Baxter Logo
    Not for Injection

    Tis-U-Sol® Solution
    (Pentalyte Irrigation)

    Each 100 mL contains: 800 mg Sodium Chloride, USP,
    40 mg Potassium Chloride, USP, 20 mg Magnesium
    Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium
    Phosphate, Heptahydrate, USP, 6.25 mg Monobasic
    Potassium Phosphate, NF. No antimicrobial agent has
    been added. pH 6.5 (4.0 to 7.0). Osmolarity 288
    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

    Distributed in Canada by
    Baxter Corporation
    Mississauga, ON
    L5N OC2

    07-09-68-118

    Bar Code Position Only*
    303380190041

    LOT
    EXP

    TIS-U-SOL Solution Representative Carton Label

    Carton Label

    Carton Label

    TIS-U-SOL® Solution
    (Pentalyte Irrigation)
    Pour Bottle

    1000 mL

    Qty
    12

    NDC 0338-0190-04
    2F7144

    EXP
    LOT #

    Bar Code
    (01)50303380190046(17)080630(10)G012345

  • INGREDIENTS AND APPEARANCE
    TIS-U-SOL 
    sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0190
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE800 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE40 mg  in 100 mL
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE20 mg  in 100 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE8.75 mg  in 100 mL
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, MONOBASIC6.25 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0190-0412 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
    NDANDA01850802/19/1982
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation001728059ANALYSIS(0338-0190) , MANUFACTURE(0338-0190) , LABEL(0338-0190) , PACK(0338-0190) , STERILIZE(0338-0190)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-0190)