Label: AQUACID-120- acid concentrate for hemodialysis solution, concentrate

  • NDC Code(s): 81943-604-02
  • 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 October 31, 2023

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  • SPL UNCLASSIFIED SECTION

    This is a Hemodialysis Acid Concentrate, Pyrogen-Free.

    By diluiting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014), each 1000 ml of this solucion provides:

    Sodium: 130.00 mEq/l

    Potassium: 2.00 mEq/l

    Calcium: 2.50 mEq/l

    Magnesium: 1.00 mEq/l

    Chlorides: 108.50 mEq/l

    Acetate: 3.00 mEq/l

    Dextrose: 100.00 mEq/l

    The final conductivity calculated at 25 C is 13.2 to 14.2 mS/cm.

  • Active Ingredient(s)

    Potassium Chloride

  • Purpose

    For use with 3-pump hemodialysis machines only.

  • Use

    For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.

  • Warnings

    For use with 3-pump hemodialysis machines only.

  • Do not use

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

    Using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.

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

  • 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.

  • Directions

    • By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).
  • Inactive ingredients

    Sodium chloride, calcium chloride, acetic acid, dextrose, purified water USP

  • Other information

    • Store at room temperature.
  • Package Label - Principal Display Panel

    3785 mL Label3785 mL NDC: 81943-604-02

  • INGREDIENTS AND APPEARANCE
    AQUACID-120 
    acid concentrate for hemodialysis solution, concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-604
    Route of AdministrationHEMODIALYSIS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORATE (UNII: H35KS68EE7) (CHLORATE ION - UNII:08Z8093742) POTASSIUM CHLORATE0.671 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.167 g  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 0.486 g  in 100 mL
    ACETIC ACID C-11 (UNII: 2A9OM7IPNW) 0.361 g  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) 3.5 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 21.07 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81943-604-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
    Establishment
    NameAddressID/FEIBusiness Operations
    AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-604)
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