Label: BACITRACIN- bacitracin zinc cream

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

Drug Label Information

Updated January 24, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients (in each gram):

    Bacitracin zinc 500 units

  • PURPOSE

    Purpose:

    Topical Antibiotic

  • INDICATIONS & USAGE

    Uses: First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
    • abrasions
  • WARNINGS

    Warnings: For external use only

    • do not get in eyes
    • serious burns require immediate attention

    Allergy alert: do not use if you are allergic to any of the ingredients

  • DO NOT USE

    Do not use:

    • in or near the eyes
    • over large portions of the body
    • more than 1 to 3 times daily
    • longer than 7 days unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or lasts for more than 7 days
    • a rash or other allergic reaction occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222.

  • DOSAGE & ADMINISTRATION

    Directions: do not use more than directed

    Adults and children 12 years of age and over:

    • clean the affected area
    • apply 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

    Children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: petrolatum

  • PRINCIPAL DISPLAY PANEL

    5324Bacitracinv20f.jpg

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 U  in 0.9 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0030-4144 in 1 BOX, UNIT-DOSE01/05/2021
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01/05/2021
    Labeler - HART Health (069560969)
    Registrant - HART Health (069560969)
    Establishment
    NameAddressID/FEIBusiness Operations
    WaterJel Technologies155522589manufacture(50332-0030)
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