Label: BACITRACIN ZINC 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 September 10, 2012

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  • ACTIVE INGREDIENT

    (in each gram)

    Bacitracin zinc, USP 500 units

  • PURPOSE

    First aid antibiotic

  • USES

    Helps prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only

    Allergy alert:

    • do not use if allergic to any of the ingredients
  • DO NOT USE

    • in the eyes
    • over large areas of the body
  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING THIS PRODUCT

    • do not use longer than 1 week unless directed by a doctor
  • STOP USE AND ASK A DOCTOR IF

    • 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 affected area
    • apply a small 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 59°-77°F (15°-25°C).
  • INACTIVE INGREDIENT

    White petrolatum

  • QUESTIONS?

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Repackaged By:
    Aidarex Pharmaceuticals, LLC
    Corona, CA 92880

    NDC 33261-707-01

    Bacitracin Zinc Ointment, USP

    First Aid Antibiotic Ointment

    Net WT 1 OZ (28 g)

    11051210E1                VC110188

    Image Label

    Image Label

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-707(NDC:0472-1105)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33261-707-561 in 1 CARTON
    1NDC:33261-707-0128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B03/01/2002
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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