Label: SUNMARK IODIDES TINCTURE- ethyl alcohol liquid

  • NDC Code(s): 49348-711-30
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 48%

  • Purpose

    First Aid Antiseptic                        

  • Use

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

  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product

    do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Stop use and consult doctor if the

    condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    store at room temperature

  • Inactive ingredients

    ammonium hydroxide, iodine, potassium iodide, and purified water

  • PRINCIPAL DISPLAY PANEL

    Label

    label

  • INGREDIENTS AND APPEARANCE
    SUNMARK IODIDES TINCTURE 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-711
    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
    WATER (UNII: 059QF0KO0R)  
    AMMONIA (UNII: 5138Q19F1X)  
    IODINE (UNII: 9679TC07X4)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-711-3059 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/2008
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(49348-711)
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