Label: AQUACETIC-30- cleaning solution for hemodialysis machines solution, concentrate

  • NDC Code(s): 81943-801-01
  • Packager: Aqua Medica, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 18, 2024

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  • SPL UNCLASSIFIED SECTION

    INDUSTRIAL VINEGAR FOR THE CLEANING
    OF HEMODIALYSIS MACHINES

  • ACTIVE INGREDIENT

    Glacial Acetic Acid

  • PURPOSE

    This product is used to descale and clean
    hemodialysis machines.

  • INDICATIONS & USAGE

    For use with 3-pump hemodialysis machines only, using purified water.

  • WARNINGS

    Avoid contact with skin and eyes.
    Do not mix with hypochlorite, or with hydrogen peroxide,
    or in general with any chemical base.

  • DO NOT USE

    Do not mix with hypochlorite, or with hydrogen peroxide,
    or in general with any chemical base.

  • WHEN USING

    Take appropriate security measures (protective clothing, glasses, masks).

  • STOP USE

    If you do not use the entire contents, discard the excess.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    This product is used to descale and clean
    hemodialysis machines.

  • STORAGE AND HANDLING

    Store at room temperature.

    Keep container tightly closed when not in use.

  • INACTIVE INGREDIENT

    Water.

  • PRINCIPAL DISPLAY PANEL

    AQUACETIC-30 LABEL81943-801-01

  • INGREDIENTS AND APPEARANCE
    AQUACETIC-30 
    cleaning solution for hemodialysis machines solution, concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-801
    Route of AdministrationHEMODIALYSIS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.7 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81943-801-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2023
    Labeler - Aqua Medica, S.A. de C.V. (589696442)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aqua Medica, S.A. de C.V.589696442manufacture(81943-801)
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