Label: IODINE liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 23, 2023

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  • Active Ingredient

    Iodine tincture U.S.P. 100%

    (2% Iodine)

  • Purpose

    First aid antiseptic

  • Use

    First aid to help prevent skin infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • Ask a doctor if you have

    deep or puncture wounds, animal bites or serious burns

  • When using this product

    • do not use in eyes or apply over large areas of the body
    • do not use longer than 1 week unless directed by a doctor
  • Stop use and ask a doctor if

    condition persists or gets worse

  • 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 a sterile bandage
    • if bandaged, let dry first
  • Inactive ingredients

    alcohol(47% v/v), purified water, sodium iodide

  • Other information

    product will stain skin and clothing

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

  • principal display panel

    Mountain falls

    iodine tincture U.S.P.

    first aid antiseptic

    For external use only

    CAUTION POISON

    1 FL OZ (30 mL)

    image description

  • principal display panel

    FOR EXTERNAL USE ONLY

    Swan

    Iodine Tincture USP

    First Aid Antiseptic

    Caution: Poison

    1 FL OZ (30 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    IODINE 
    iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM IODIDE (UNII: F5WR8N145C)  
    ALCOHOL (UNII: 3K9958V90M)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0088-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/07/2017
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0869-0088)