Label: FIRST AID ANTISEPTIC- povidone-iodine ointment

  • 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 October 28, 2020

If you are a consumer or patient please visit this version.

  • 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) 645-2158

  • 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 not finalpart333A11/03/2020
    Labeler - Rugby Laboratories (079246066)