Label: FIRST AID ANTISEPTIC- povidone-iodine ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 9, 2024

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  • Drug Facts

  • 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 
    • burns
  • Warnings

    For external use only.

    Do not use

    • if you are allergic to any of the ingredients
    • over large areas of the body 
    • longer than 1 week unless directed by a doctor 
    • in the eyes

    Ask a doctor before use if you have

    • deep or puncture wounds 
    • animal bites 
    • serious burns

    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 Center (1-800-222-1222) right away.

  • 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
  • Other information

    • store at controlled room temperature 20° to 25°C (68° to 77°F) 
    • close cap tightly after use
  • Inactive ingredients

    mineral oil, petrolatum

  • Questions or comments?

    1-800-639-3803

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    povidone-iodine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1271
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1271-801 in 1 BOX11/03/2020
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/03/2020
    Labeler - Rugby Laboratories (079246066)
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