Label: POVIDONE IODINE- povidone iodine 10% ointment

  • NDC Code(s): 69396-112-20
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 9, 2023

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  • Active Ingredient

    Povidone Iodine USP 10%

    w/w (available iodine 1%)

  • Purpose

    First Aid Antiseptic

  • Uses

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

  • Warnings

    For external Use Only

    Do not use

    • in eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
  • Directions

    • Clean the affected area
    • apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
    • may be covered with a sterile bandage
  • Ask Doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Inactive Ingredients

    Polyethylene glycol 400, Polyethylene glycol 4000

  • Questions?

    Call 1-888-296-9067

  • Stop Use and Ask a doctor if

    • The condition persists or gets worse
    • you need to use this product for more than 1 week
  • Storage Information

    • Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF).
    • close cap tightly after use.
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.

  • Questions

    1-888-296-9067

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Ave. Ste 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    globe povidone iodine ointment 1oz CDER

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine 10% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-112-201 in 1 BOX12/23/2022
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/23/2022
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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