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: 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

    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
    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(81943-601)
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