Label: JCI MN COLLOIDAL IODINE EYE WASH CLEANSING WATER (QUASI DRUG)- iodine solution

  • NDC Code(s): 69164-3002-1
  • Packager: JCI INSTITUTE OF MEDICAL SCIENCE
  • 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 May 11, 2018

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  • ACTIVE INGREDIENT

    sodium iodide


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  • INACTIVE INGREDIENT

    electrolytic-reduction water


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  • PURPOSE

    opthalmic disorders
    intranasal lesion, intra-oral lesion
    prevention of the diseases above mentioned


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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


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  • INDICATIONS & USAGE

    apply eyewash several times a day in case of ophthalmic disorders
    adjust the mumber of times being applying the eye drop, depending on symptho
    it is better to increase the number of times for the quick recovery
    for the intranasal disease, it is recommended to apply the drops several times a day
    for the intra-oral disease, keep the drop in the mouth or use as toothpaste



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  • WARNINGS

    there may occurs the case of irritability when applying eye drop or nasal drop
    do not worry about it because it is caused by the reaction of Iodine
    But is it possibly think of the susceptibility to Iodine, which seldom occurs.
    in case of irritability or rash, stop the use immediately and discuss with doctors
    keep out of the direct sunlight


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  • DOSAGE & ADMINISTRATION

    ophthalmic and intranasal use


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  • INGREDIENTS AND APPEARANCE
    JCI MN COLLOIDAL IODINE EYE WASH CLEANSING WATER (QUASI DRUG) 
    iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69164-3002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69164-3002-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 02/01/2015
    Labeler - JCI INSTITUTE OF MEDICAL SCIENCE (692347047)
    Registrant - JCI INSTITUTE OF MEDICAL SCIENCE (692347047)
    Establishment
    Name Address ID/FEI Business Operations
    JCI INSTITUTE OF MEDICAL SCIENCE 692347047 manufacture(69164-3002)
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