Label: ACETIC ACID irrigant

  • NDC Code(s): 0990-6143-09, 0990-6143-22
  • Packager: ICU Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 17, 2020

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  • SPL UNCLASSIFIED SECTION
    UROLOGIC IRRIGATING FLUID FOR PATIENTS REQUIRING PROLONGED INDWELLING URETHRAL CATHETERIZATION...NOT FOR TRANSURETHRAL SURGICAL PROCEDURES. Not For Injection By Usual Parenteral ...
  • DESCRIPTION
    0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic aqueous solution of Glacial Acetic Acid, USP for irrigation of the urinary bladder by the transurethral route (NOT FOR TUR). Each 100 ...
  • CLINICAL PHARMACOLOGY
    Irrigation of the urinary bladder with acetic acid solution in a concentration of 0.25% has been shown to exert an antimicrobial action against a variety of microorganisms (especially ...
  • 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 ...
  • CONTRAINDICATIONS
    NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. This solution is contraindicated for irrigation during transurethral surgical procedures.
  • WARNINGS
    FOR IRRIGATION ONLY. NOT FOR INJECTION. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesions. Absorption via open lesions ...
  • PRECAUTIONS
    If pain or hematuria should occur during irrigation, it should be discontinued and the patient re-evaluated. Do not use unless solution is clear, seal is intact and container is undamaged. Discard ...
  • ADVERSE REACTIONS
    Systemic acidosis has been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. Urologic pain and hematuria have been reported in patients receiving urinary ...
  • OVERDOSAGE
    Systemic absorption is unlikely unless there are open lesions of the bladder mucosa that have gone undetected. In such event, discontinue the irrigation, evaluate the patient for possible systemic ...
  • DOSAGE AND ADMINISTRATION
    0.25% Acetic Acid Irrigation, USP may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. A ...
  • HOW SUPPLIED
    0.25% Acetic Acid Irrigation, USP is supplied in single-dose irrigation containers as follows: List - Container - Size (mL) 6143 - Semi-rigid - 250 & 1000 - Exposure of pharmaceutical ...
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
    1000 mL - NDC 0990-6143-09 - 0.25% ACETIC ACID - Irrigation, USP - Each 100 mL contains glacial acetic - acid, 250 mg. 42 mOsmol/liter - (calc.). pH 3.1 (2.8 to 3.4). Sterile, nonpyrogenic. Not for ...
  • INGREDIENTS AND APPEARANCE
    Product Information