Label: IODINE TINCTURE MILD- iodine and sodium iodide and alcohol liquid

  • NDC Code(s): 0395-1213-16, 0395-1213-55, 0395-1213-91
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Iodine 2%

  • Purpose

    First Aid Antiseptic

  • Active ingredient

    Sodium Iodide 2.4%

  • Purpose

    First Aid Antiseptic

  • Active ingredient

    Alcohol 47%

  • Purpose

    First Aid Antiseptic

  • Indications

    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
    • Flammable: Keep away from sparks heat and flame

    Stop use and consult doctor if

    • the condition persists or gets worse, or if using for longer than one 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 reach of children.

    In case of accidental ingestion, give milk then a starch solution made by mixing two tablespoonfuls of cornstarch or flour to a pint of water. Contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply a small amount on the area 1 to 3 times daily
    • may be covered with sterile bandage
    • if bandaged let dry first
  • Other information

    • will stain skin and clothing
  • Inactive ingredient

    Purified Water

  • Old Label



    Principal Display Panel NDC 0395-1213-16 IODINE TINCTURE 2% MILD USP ALCOHOL 47% 16 FL OZ(30mL)

  • New Label

    New Label

  • INGREDIENTS AND APPEARANCE
    IODINE TINCTURE MILD 
    iodine and sodium iodide and alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 mg  in 1 mL
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION20.4 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL470 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1213-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/14/2017
    2NDC:0395-1213-9130 mL in 1 BOTTLE; Type 0: Not a Combination Product11/14/2017
    3NDC:0395-1213-55208000 mL in 1 DRUM; Type 0: Not a Combination Product02/21/201412/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/1979
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-1213) , analysis(0395-1213) , pack(0395-1213) , label(0395-1213)
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