BACITRACIN ZINC OINTMENT [ACTAVIS PHARMA, INC.]

BACITRACIN ZINC OINTMENT [ACTAVIS PHARMA, INC.]
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NDC 0472-1105-26, 0472-1105-34, 0472-1105-56
Set ID c0c78393-31de-49ef-bd0a-f636f24657b5
Category HUMAN OTC DRUG LABEL
Packager Actavis Pharma, Inc.
Generic Name
Product Class
Product Number
Application Number PART333B
  • 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 finalpart333B06/01/199701/31/2023
    Labeler - Actavis Pharma, Inc. (119723554)