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: 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

    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
    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(81943-701)
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