Label: BACITRACIN ZINC- bacitracin zinc ointment

  • NDC Code(s): 55319-110-56
  • Packager: Family Dollar Services Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active Ingredient (in each gram)

    Bacitracin zinc, USP 500 units

    Close
  • Purpose

    First aid antibiotic

    Close
  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
    Close
  • Warnings

    For external use only

    Close
  • Allergy alert:

    • do not use if allergic to any of the ingredients
    Close
  • Do not use

    • in the eyes
    • over large areas of the body
    Close
  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
    Close
  • When using this product

    • do not use longer than 1 week unless directed by a doctor
    Close
  • Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or other allergic reaction develops
    Close
  • Keep out of reach of children

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

    Close
  • Directions

    • clean 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
    Close
  • Other information

    • Store at room temperature 59°-77°F (15°-25°C).
    • Before using any medication, read all label directions.  Keep carton to reference important product information.
    Close
  • Inactive ingredient

    White petrolatum

    Close
  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

    Close
  • PRINCIPAL DISPLAY PANEL

    FAMILY wellness™
    Bacitracin Zinc Ointment, USP
    First Aid Antibiotic
    Helps prevent infection in minor cuts, scrapes and burns

    NET WT 1 OZ (28 g)

    family wellness-bacitracin label1
    Close
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55319-110
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-110-56 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333B 02/23/2012
    Labeler - Family Dollar Services Inc. (024472631)
    Close