Label: SUNMARK IODINE- iodine, sodium iodide, alcohol tincture

  • NDC Code(s): 49348-133-27
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • Active Ingredients

    Iodine  2%,  Sodium Iodide 2.4%,  Alcohol 47%

  • Purpose

    Antiseptic

  • Uses

    To help prevent infection in minor cuts, scrapes and burns.

  • WARNINGS:

    For external use only.

  • DIRECTIONS:

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

  • Inactive ingredient:

    Purified Water.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    Iodine

  • INGREDIENTS AND APPEARANCE
    SUNMARK IODINE 
    iodine, sodium iodide, alcohol tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL470 mg  in 1 mL
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-133-2730 mL in 1 BOTTLE; Type 0: Not a Combination Product08/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/28/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(49348-133) , pack(49348-133) , label(49348-133) , analysis(49348-133)
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