Label: CITRACID-50- desinfectant solution for hemodialysis machine solution, concentrate

  • NDC Code(s): 81943-701-01
  • 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

    This product is used to descale and desinfect Hemodialysis machines.

  • ACTIVE INGREDIENT

    Citric Acid

  • PURPOSE

    For use with 3-pump hemodialysis machines only.

  • INDICATIONS & USAGE

    For use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019).

  • WARNINGS

    Avoid contact with skin an eyes.

    Irritation hazard if spilled or splashed.

  • DO NOT USE

    If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.

  • WHEN USING

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

    Wash splashes on skin or clothing with plenty of water.

  • STOP USE

    If 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

    By diluting one part of this acid concentrate with one part of purified water.

  • STORAGE AND HANDLING

    Store at room temperature.

    Keep container tightly closed when not in use.

  • INACTIVE INGREDIENT

    Water.

  • PRINCIPAL DISPLAY PANEL

    CITRACID-50 LABEL

  • INGREDIENTS AND APPEARANCE
    CITRACID-50 
    desinfectant solution for hemodialysis machine solution, concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-701
    Route of AdministrationHEMODIALYSIS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.5 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81943-701-015000 mL in 1 CONTAINER; 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(81943-701)
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