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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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)