Label: IODINE- iodine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 3, 2018

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Iodine tincture U.S.P. 2%

    Close
  • Purpose

    First aid antiseptic

    Close
  • Use

    First aid to help prevent skin infection in

    • minor cuts
    • scrapes
    • burns
    Close
  • Warnings

    For external use only

    Close
  • Ask a doctor before use

    if you have deep or puncture wounds, animal bites or serious burns.

    Close
  • 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
    Close
  • Stop use and ask a doctor if

    condition persists or gets worse

    Close
  • Keep out of reach of children.

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

    Close
  • 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
    Close
  • Inactive ingredients

    None

    Close
  • Other information

    product will stain skin and clothing

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by: Vi-Jon, Inc., 8515 Page Ave., St. Louis, MO 63114

    Close
  • Principal Display Panel

    GoodSense

    Iodine tincture u.s.p.

    First aid antiseptic

    For external use only

    CAUTION: POISON

    1 FL OZ (30 mL)

    image description

    088.000/088AA

    Close
  • INGREDIENTS AND APPEARANCE
    IODINE 
    iodine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-088
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 20 mg  in 1 mL
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 20.4 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 470 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11344-088-10 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/08/2008
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/08/2008
    Labeler - Vi-Jon (150931459)
    Registrant - Vi-Jon (150931459)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding Group, Inc 825672884 manufacture(11344-088)
    Close