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Acetic Acid (Baxter Healthcare Corporation)

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IRRIGANT 1000 mL in 1 BOTTLE, PLASTIC (0338-0656-04) Label Information

Complete Acetic Acid Information

  • DESCRIPTION

    0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic hypotonic solution for irrigation of the urinary bladder. Each 100 mL contains 250 mg Glacial Acetic Acid, USP, (CH3COOH) in Water for Injection, USP. pH 3.0 (2.8 to 3.4). Osmolarity: 42 mOsmol/L (calc.). No antimicrobial agent has been added.

    The container is made from specially formulated polyolefin (PL 325). The polyolefin is a copolymer of ethylene and propylene. It contains no plasticizers or other mobile additives. As a result, the container has virtually no extractability or leachability. The total extractables after two years of storage being less than 0.01 ppm. It is also relatively impermeable to water vapor transmission and, therefore, requires no vapor barrier to maintain the proper drug concentration.


  • CLINICAL PHARMACOLOGY

    The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.


  • INDICATIONS AND USAGE

    0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.


  • CONTRAINDICATIONS

    None known


  • WARNINGS

    Not for injection.

    Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion. Absorption via open lesions of the bladder mucosa may result in systemic acidosis.

    The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.


  • PRECAUTIONS

    Pregnancy

    Teratogenic Effects

    Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation, USP. It is also not known whether 0.25% Acetic Acid Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to a pregnant woman only if clearly needed.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.

    Do not administer unless the solution is clear and the seal is intact.


  • ADVERSE REACTIONS

    Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% Acetic Acid Irrigation, USP.

    Should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.


  • DOSAGE AND ADMINISTRATION

    The volume of solution needed will vary with nature and duration of the urologic procedure, according to physician’s instructions.

    Irrigation drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.


  • HOW SUPPLIED

    0.25% Acetic Acid Irrigation, USP is supplied in a plastic pour bottle as follows:

    2F7184

    1000 mL

    NDC 0338-0656-04

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C): brief exposure up to 40ºC does not adversely affect the product.


  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in USA

    Baxter is a registered trademark of Baxter International Inc.

    07-19-00-0228

    Rev. February 2018


  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    Acetic Acid Representative Container Label  NDC 0338-0656-04

    Container Label

    Not for Injection 2F7184
    NDC 0338-0656-04

    0.25% Acetic Acid
    Irrigation, USP

    1000 mL

    Each 100 mL contains: 250 mg Glacial Acetic Acid,
    USP. No antimicrobial agent has been added.
    pH 3.0 (2.8 to 3.4). Osmolarity 42 mOsmol/L
    (calc.). Sterile, nonpyrogenic. Pour Bottle.
    Hypotonic solution for irrigation only. Dosage and
    Administration: As directed by a physician. See
    directions. 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. See insert.

    PL 325 plastic

    Baxter Logo
    Baxter Healthcare Corporation

    Deerfield, IL 60015 USA

    Made in USA

    07-09-74-482

    LOT
    EXP

    Bar Code Posit ion Only*
    (01) 00303380656042

    Acetic Acid Representative Carton Label  NDC 0338-0656-04

    Carton Label

    0.25% Acetic Acid
    Irrigation, USP
    Pour Bottle

    1000 ML

    NDC 0338-0656-04 2F7184

    EXP JUN 08 LOT# G012345

    Qty 12

    (01)50303380656047 (17)080630(10)G012345


  • INGREDIENTS AND APPEARANCE
    ACETIC ACID 
    acetic acid irrigant
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0656
    Route of Administration IRRIGATION
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 250 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0656-04 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1982
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018523 02/19/1982
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 001728059 MANUFACTURE(0338-0656) , ANALYSIS(0338-0656) , PACK(0338-0656) , LABEL(0338-0656) , STERILIZE(0338-0656)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0656)