Label: BACITRACIN ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 4, 2023

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  • Active ingredient (each gram contains)

    Bacitracin 500 units

  • Purpose

    First aid antibiotic

  • Uses

    first aid to help prevent infection in:

    minor cuts
    scrapes
    burns
  • Warnings

    For external use only

    Do not use

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

    Ask a doctor before use if you have

    deep or puncture wounds
    animal bites
    serious burns

    Stop use and ask a doctor if

    you need to use longer than 1 week
    condition persists or gets worse
    rash or other allergic reaction develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    clean the affected area
    apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    may be covered with a sterile bandage
  • Other information

    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    light mineral oil, white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Bacitracin

    Label Image
  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0845(NDC:45802-060)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0845-0144 in 1 CARTON11/28/2014
    1.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/20/2011
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0845)