BACITRACIN ZINC OINTMENT [AIDAREX PHARMACEUTICALS LLC]

BACITRACIN ZINC OINTMENT [AIDAREX PHARMACEUTICALS LLC]
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NDC 33261-707-01, 33261-707-56
Set ID aee808f9-e759-4129-9661-29c2a3bd9a30
Category HUMAN OTC DRUG LABEL
Packager Aidarex Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART333B
  • 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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