Label: IDC 20 CONCENTRATE- iodine solution, concentrate

  • NDC Code(s): 33392-550-08, 33392-550-50, 33392-550-60, 33392-550-99
  • Packager: WestAgro, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 15, 2021

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  • SPL UNCLASSIFIED SECTION

    A concentrated iodophor for manufacturing use in FDA registered facilities only

  • ACTIVE INGREDIENT

    Active Ingredients:
    Titratable Iodine ................................................ 20.0%
    INERT INGREDIENTS ......................................... 80.0%
                                                TOTAL: .............. 100.0%

    From Nonylphenoxypoly(ethyleneoxy)ethanol-iodine complex

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    ! DANGER

  • SPL UNCLASSIFIED SECTION

    STATEMENT OF PRACTICAL TREATMENT

    In case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes.  For eyes, call a physician.  If swallowed, drink promptly a large quantity of water.  Do not induce vomiting.  Avoid alcohol.  Get medical attention.  Remove and wash all contaminated clothing before reuse.

    NOTE TO PHYSICIAN:  Probable mucosal damage may contraindicate the use of gastric lavage.  Measures against circulatory shock, respiratory depression and convulsions may be needed.

  • SPL UNCLASSIFIED SECTION

    Chemtrec Emergency No.

        1-800-424-9300

  • SPL UNCLASSIFIED SECTION

    Manufactured by:    WESTAGRO
                                11100 N. Congress Avenue
                                Kansas City, MO  64153

  • SPL UNCLASSIFIED SECTION

    KEEP OUT OF REACH OF CHILDREN

    ! DANGER

  • WARNINGS AND PRECAUTIONS

    PRECAUTIONARY STATEMENTS:  HAZARDS TO HUMANS AND DOMESTIC ANIMALS

    DANGER.  Corrosive.  Avoid breathing vapors.  Causes irreversible eye damage.  Harmful if swallowed.  Do not get in eyes or on clothing.  Avoid contact with skin.  Wear goggles or face shield.  Wash thoroughly with soap and water after handling.  Remove contaminated clothing and wash before reuse.

    ENVIRONMENTAL HAZARDS

    This product is toxic to fish.  Keep out of lakes, ponds or streams.  Do not contaminate water by cleaning of equipment or disposal of wastes.  Do not discharge into lakes, streams, ponds or public waters unless in accordance with a NPDES permit.  For guidance, contact the regional office of EPA.

  • STORAGE AND HANDLING

    STORAGE AND DISPOSAL

    Keep container closed when not in use.  Do not store below 25 deg F or above 100 deg F for extended periods.

    Prohibitions:  Do not contaminate water, food or feed by storage or disposal.  Open dumping is prohibited.

    Container Disposal:  Triple rinse (or equivalent).  Then offer for recycling, reconditioning or incineration.  May puncture and dispose of in a sanitary landfill or burn, if allowed by State and local authorities.  If burned, stay out of smoke.

  • INDICATIONS & USAGE

    DIRECTIONS FOR USE

    Manufacturing instructions must be developed by the formulator prior to use of this product.
    Consult Material Safety Data Sheet before using.
    NOTE TO FORMULATOR:  Mix well in drum before sampling and before each use.  Avoid contact with soft metals.
    IDC 20 CONCENTRATE will flow and mix more easily if a day or two prior to formulating it is gradually warmed to 70 deg F - 100 deg F and then slowly added in a thin stream while mixing.

    IDC 20 CONCENTRATE is an iodophor concentrate based on iodine and non-ionic surfactants.  It is specially formulated as a base of manufacturing topical iodine products.
    IDC 20 CONCENTRATE contains no phosphates.
    IDC 20 CONCENTRATE may be used to manufacture topical animal health care products and related antimicrobials.  IDC 20 CONCENTRATE is not intended for use as a component of iodophor based sanitizers and disinfectants.
    It is the responsibility of the distributor of topical antimicrobials to obtain any necessary regulatory approval from the Food and Drug Administration for products formulated from IDC 20 CONCENTRATE which carry specific label directions for treatment or prevention of animal diseases.

  • SPL UNCLASSIFIED SECTION

    0550-A0404        Made in U.S.A.

  • SPL UNCLASSIFIED SECTION

    0550

    CORROSIVE

    8

    DOT SHIPPING NAME
    Corrosive liquid, acidic,
    inorganic, N.O.S., (Contains
    Iodine), 8, UN 3264, PG II

  • SPL UNCLASSIFIED SECTION

    NET CONTENTS:

    LOT NO:

    EXPIRATION DATE:

  • PRINCIPAL DISPLAY PANEL

    Product Container Label

  • INGREDIENTS AND APPEARANCE
    IDC 20 CONCENTRATE 
    iodine solution, concentrate
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:33392-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine200 g  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33392-550-60271.8 kg in 1 DRUM
    2NDC:33392-550-991132.5 kg in 1 TANK
    3NDC:33392-550-0823.6 kg in 1 PAIL
    4NDC:33392-550-501246 kg in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2012
    Labeler - WestAgro, Inc. (069288728)
    Registrant - WestAgro, Inc. (069288728)
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.147528723analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    K Klean dba WestAgro, Inc.002222368analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.095906480analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label