Label: COLLOIDAL IODINEINJECTION- iodine solution

  • NDC Code(s): 69164-0001-1
  • Packager: JCI Colloidal Iodine Laboratory Co., Ltd.
  • 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 May 17, 2023

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  • ACTIVE INGREDIENT

    iodine

  • INACTIVE INGREDIENT

    potassium iodide, hydrogen water

  • PURPOSE

    disinfection effect

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Consult a physician before use

  • WARNINGS

    For subcutaneous use only

    keep in a room temperature

    keep out of the direct sunlight

  • DOSAGE & ADMINISTRATION

    for subcutaneous use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COLLOIDAL IODINEINJECTION 
    iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69164-0001
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69164-0001-150 mL in 1 BOTTLE, GLASS; Type 1: Convenience Kit of Co-Package05/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/18/2023
    Labeler - JCI Colloidal Iodine Laboratory Co., Ltd. (717705036)
    Registrant - JCI Colloidal Iodine Laboratory Co., Ltd. (717705036)
    Establishment
    NameAddressID/FEIBusiness Operations
    JCI COLLOIDAL IODINE LABORATORY CO., LTD.717705036manufacture(69164-0001)