Label: JCI MN COLLOIDAL IODINE CREAM- glycerin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 11, 2018

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    water, sorbitol, glyceryl stearate, isopropyl palmitate, stearic acid, dimethicone, mineral oil, malmiticacid, aloe barbadensis leaf ext, squalane oil, jojoba oil, rosemary oil, pca-na, betaine, serine, glutamic acid, alanine, lycine, arginine, threonine, proline, aminocaproic acid, methylparaben, propylparaben, phenoxyethanol, sodiumhydrogen-n(-1-oxooctadecyl)-L glutamate, sodium copper-chlorophyllin, sodium iodide


  • PURPOSE

    skin ailments
    external lesion on the skin
    lesion on the scalp
    secondary infectin of the lesions described on the above
    female external genitals
    functionality change on the skin
    cosmetic use as basic lotion
    diseases of oral cavity


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply the cream to the diseased part
    adjust the number of times being applying the cream, depending on symptom
    it is better to increase the number of times for the quick recovery
    for the oral disease, it is recommended to mop the cream after applying the medium dose several times a day


  • WARNINGS

    do not use for ophthalmology because the safety for such use is not yet examined
    keep in a room temperature
    keep out of the direct sunlight


  • DOSAGE & ADMINISTRATION

    topical use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    JCI MN COLLOIDAL IODINE CREAM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69164-1002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    THREONINE (UNII: 2ZD004190S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69164-1002-130 mL in 1 JAR; Type 0: Not a Combination Product05/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2015
    Labeler - JCI INSTITUTE OF MEDICAL SCIENCE (692347047)
    Registrant - JCI INSTITUTE OF MEDICAL SCIENCE (692347047)
    Establishment
    NameAddressID/FEIBusiness Operations
    JCI INSTITUTE OF MEDICAL SCIENCE692347047manufacture(69164-1002)
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