Label: DRY-CID- dry concentrate for hemodialysis powder, for solution

  • NDC Code(s): 81943-601-01
  • 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

    By diluting the contents of this box to complete 20
    gal (75.70 l), one part of this acid concentrate with
    44 parts of purified water (UNE-EN ISO
    23500-3:2019 standard) will have the following
    concentrations:
    Sodium
    Potassiu m
    Calcium
    Magnesium
    chlorides
    Acetate
    Dextrose
    The final conductivity calculated at 25°C It is 13,2 to 14,2 mS/cm
    NON STERILE PRODUCT
    100,00 mEq/l
    2,00 mEq/l
    2,50 mEq/l
    1,00 mEq/l
    105,50 mEq/l
    4,00 mEq/l
    100,00 mg/dl

  • ACTIVE INGREDIENT

    Potassium Chlorate

  • PURPOSE

    For use with 3-pump hemodialysis machines only.

  • INDICATIONS & USAGE

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

  • 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 conbination with sodium bicarbonate.

  • 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

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

  • STORAGE AND HANDLING

    Store at room temperature.

    Keep container tightly closed when not in use.

  • INACTIVE INGREDIENT

    Sodium Chloride, Anhydrous Calcium Chloride, Anhydrous Magnesium Chloride, Acetic Acid, Dextrosa

  • PRINCIPAL DISPLAY PANEL

    DRY-CID LABEL81943-601-01

  • INGREDIENTS AND APPEARANCE
    DRY-CID 
    dry concentrate for hemodialysis powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-601
    Route of AdministrationHEMODIALYSIS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORATE (UNII: H35KS68EE7) (CHLORATE ION - UNII:08Z8093742) POTASSIUM CHLORATE0.51 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 19.91 kg  in 100 kg
    CALCIUM CHLORIDE ANHYDROUS (UNII: OFM21057LP) 0.47 kg  in 100 kg
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM) 0.16 kg  in 100 kg
    ACETIC ACID (UNII: Q40Q9N063P) 0.82 kg  in 100 kg
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 3.41 kg  in 100 kg
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81943-601-0125.28 kg in 1 BOX; Type 0: Not a Combination Product08/30/2023
    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(81943-601)
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