Label: BACITRACIN- bacitracin zinc cream

  • 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 November 22, 2022

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

  • 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

    5324 Bacitracin v20f.jpg5324 Bacitracin v20f.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 finalpart333B01/05/2021
    Labeler - HART Health (069560969)
    Registrant - HART Health (069560969)
    Establishment
    NameAddressID/FEIBusiness Operations
    WaterJel Technologies155522589manufacture(50332-0030)