Label: COLLOIDAL IODINE SOLUTION- sodium iodide solution

  • NDC Code(s): 69164-0003-1
  • 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 23, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    iodine

  • INACTIVE INGREDIENT

    potassium iodide, hydrogen water

  • PURPOSE

    increase level of immunity, digestive trouble

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    it is better to dose on an empty stomach

    the dosage on undiluted solution is possibly recommended

    do eat nothing within five minutes after the dosage

    unit dose is 30ml

    do take unit dose three times a day before each meal

    (morning, daylight, evening)

    keep this dose guide for a month

    if effective, do change the unit dose twice a day before each meal

    (morning, evening)

    do discuss with your doctor for further dose

  • WARNINGS

    do possibly avoid the food containing an antioxidant and color additives

    do take the greatest possible care to eggs, milk, cheese and tuna

    do take before meal. in case of other medicine dose, do take colloidal

    iodine within on hour before you take other medicine

    do eat nothing within five minutes after the dosage

    keep out of the direct sunlight

  • DOSAGE & ADMINISTRATION

    for oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COLLOIDAL IODINE SOLUTION 
    sodium iodide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69164-0003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69164-0003-1500 mL in 1 BOTTLE; 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(69164-0003)