Label: POVIDONE IODINE- povidone iodine antiseptic 5% solution solution

  • NDC Code(s): 83254-105-01, 83254-105-02, 83254-105-05, 83254-105-10, view more
    83254-105-11, 83254-105-15, 83254-105-18, 83254-105-20, 83254-105-22, 83254-105-25, 83254-105-50, 83254-105-60, 83254-105-66, 83254-105-90
  • Packager: 1201258 Ontario Inc. O/A Nanz Pharma
  • 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 May 25, 2023

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  • Active Ingredient

    Povidone-Iodine USP 5%

    0.5% available iodine

  • Purpose:

    Topical Antiseptic

  • Warnings:

    For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and ask a doctor if the condition persists or gets worse. Stop use and ask doctor if redness, irritation, swelling, or pain persists, and infection occurs. Do not use longer than 1 week unless directed by a doctor. Do not use if allergic to iodine, in the eyes. Avoid pooling beneath the patient. Avoid excessive heat. Store at room temperature.

  • Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions:

    Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

  • Use:

    Antiseptic skin preparation

  • Other information

    - not made with natural rubber latex

    - for hospital and professional use only.

  • Inactive ingredients:

    InAnhydrous dibasic sodium phosphate, citric acid monohydrate, glycerin, polyethylene glycol 1500, nonoxynol-9, potassium iodate, water

  • Questions:

    Nanz Pharma Inc., 575 Granite Court, Pickering, ON, L1W 3K1, Canada

  • Label for 5% solution

    Label for all povidone iodine 5 percentLabel for all povidone iodine 5 percent

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine antiseptic 5% solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM IODATE (UNII: I139E44NHL)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83254-105-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    2NDC:83254-105-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    3NDC:83254-105-25225 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    4NDC:83254-105-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    5NDC:83254-105-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    6NDC:83254-105-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    7NDC:83254-105-50250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    8NDC:83254-105-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    9NDC:83254-105-9090 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    10NDC:83254-105-20120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    11NDC:83254-105-18118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
    12NDC:83254-105-1130 mL in 1 POUCH; Type 0: Not a Combination Product06/07/2023
    13NDC:83254-105-2222.5 mL in 1 POUCH; Type 0: Not a Combination Product06/07/2023
    14NDC:83254-105-6660 mL in 1 POUCH; Type 0: Not a Combination Product06/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/07/2023
    Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
    Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
    Establishment
    NameAddressID/FEIBusiness Operations
    1201258 Ontario Inc. O/A Nanz Pharma256906595manufacture(83254-105) , pack(83254-105) , label(83254-105)
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