Label: LEADER 2% MILD IODINE TINCTURE- iodine and sodium iodide and alcohol liquid 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 March 17, 2022

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  • ACTIVE INGREDIENT

    Iodine 2%

    Sodium Iodide 2.4%

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • DOSAGE & ADMINISTRATION

    Clearn the affected area

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

  • PURPOSE

    First Aid Antiseptic

  • INACTIVE INGREDIENT

    Alcohol 47%

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    mildiodine

  • INGREDIENTS AND APPEARANCE
    LEADER 2% MILD IODINE TINCTURE 
    iodine and sodium iodide and alcohol liquid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION24 mg  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0401-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/15/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
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