QUALITY CHOICE IODIDES TINCTURE (ETHYL ALCOHOL) LIQUID [CHAIN DRUG MARKET ASSOCIATION]

QUALITY CHOICE IODIDES TINCTURE (ETHYL ALCOHOL) LIQUID [CHAIN DRUG MARKET ASSOCIATION]
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NDC 63868-331-02
Set ID 71aedfd5-e81f-4b69-b163-527ff1ce30b1
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Market Association
Generic Name
Product Class
Product Number
Application Number PART333A
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Alcohol 45 % denatured with ammonia, Ammonium and Potassium Iodides.

  • Purpose

    Antiseptic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only.

  • Ask a doctor before use if you have

    deep or puncture wounds, animal bites, serious burns.

  • Stop use and ask a doctor if:

    The condition persists or gets worse, or if using this product for longer than 1 week.

  • When using this product:

    Do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids. Do not apply over large areas of the body.

  • Keep out of the reach of children.

    In case of acidental ingestion give milk, then give a starch solution made by mixing two tablespoonfools of cornstarch or flour to a pint of water. contact a poison Control Center immediately.

  • Directions

    Clean the affected area. Aply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let it dry first.

  • Inactive Ingredient:

    Purified Water

  • Other Information:

    Will stain skin and clothing. FLAMMABLE: Keep away from spark, heat & flame.

  • Principal Package Display

    QCDecolorized.jpgLabel 60 ml

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE IODIDES TINCTURE 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.45 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    IODINE (UNII: 9679TC07X4)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-331-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/1998
    Labeler - Chain Drug Market Association (011920774)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(63868-331) , analysis(63868-331) , pack(63868-331) , label(63868-331)