Label: BACITRACIN ZINC ointment

  • NDC Code(s): 0472-1105-26, 0472-1105-34, 0472-1105-56
  • Packager: Actavis Pharma, Inc.
  • 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 19, 2019

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  • ACTIVE INGREDIENT (in each gram)

    Bacitracin zinc, USP 500 units

  • PURPOSE

    First aid antibiotic

  • USES

    First aid to help prevent infection in   •minor cuts   •scrapes   •burns

  • WARNINGS

    For external use only

  • SPL UNCLASSIFIED SECTION

    ALLERGY ALERT:   •do not use if allergic to any of the ingredients

  • DO NOT USE

    DO NOT USE    •in the eyes   •over large areas of the body

  • ASK DOCTOR

    ASK A DOCTOR BEFORE USE IF YOU HAVE   •deep or puncture wounds   •animal bites  •serious burns

  • WHEN USING

    WHEN USING THIS PRODUCT   •do not use longer than 1 week unless directed by a doctor

  • STOP USE

    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

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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

  • OTHER INFORMATION

    •Store at room temperature 59°-77°F (15°-25°C).   •Before using any medication, read all label directions.  Keep carton, it contains important information.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT    white petrolatum

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Actavis

    NDC 0472-1105-34
    Bacitracin Zinc Ointment, USP
    First Aid Antibiotic

    Prevents Infection in Minor Curts, Scrapes, and Burns

    New wt. 0.5 oz (14g)

    Bacitracin Zinc Ointment
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0472-1105-341 in 1 CARTON06/01/1997
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0472-1105-261 in 1 CARTON06/01/1997
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0472-1105-561 in 1 CARTON06/01/1997
    328 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B06/01/1997
    Labeler - Actavis Pharma, Inc. (119723554)
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