Label: BACITRACIN ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • ACTIVE INGREDIENT

    Bacitracin 500 units

  • PURPOSE

    First aid antibiotic

  • USES

    first aid to help prevent infection in minor cuts, scrapes and burns

  • WARNINGS

    For external use only
    Do not use
    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if
    • the condition persists or gets worse
    • a 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 room temperature

  • INACTIVE INGREDIENT

    light mineral oil, white petrolatum

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Bacitracin Ointment
    First Aid Antibiotic
    NET WT. 1 OZ (28.4g)

    71205-057-01
  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-057(NDC:0713-0280)
    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:71205-057-0128.4 g in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00401/10/1995
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-057) , RELABEL(71205-057)
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