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: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 28, 2023

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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
    OTC monograph not finalpart35603/30/2023
    Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
    Establishment
    NameAddressID/FEIBusiness Operations
    AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-801)
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