Label: IODINE TINCTURE solution/ drops

  • 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 January 19, 2023

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  • Active ingredient

    Iodine 2%

  • 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 before use

    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 Canter 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
  • Other Information

    product will stain skin and clothing

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

    TOPCO VIJA0622 QUESTIONS? 1-888-423-0139

    topcare@topco.com www.topcarebrand.com

    Visit here for more information: http://topbrnds.com/4901ji

  • principal display panel

    TopCare

    health

    Iodine Tincture USP

    FIRST AID ANTISEPTIC

    For External Use Only

    CAUTION POISON

    1 FL OZ (30mL)

    image description

  • INGREDIENTS AND APPEARANCE
    IODINE TINCTURE 
    iodine tincture solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-088
    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
    ALCOHOL (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    SODIUM IODIDE (UNII: F5WR8N145C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-088-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2022
    Labeler - Topco associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(76162-088)
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