BACITRACIN ZINC OINTMENT [PROMEX, LLC]

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BACITRACIN ZINC OINTMENT [PROMEX, LLC]
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NDC 58988-0031-1
Set ID f1f7ba23-6a90-4eaa-8eeb-d73db774b863
Category HUMAN OTC DRUG LABEL
Packager Promex, LLC
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Active ingredient (in each gram)

    Bacitracin Zinc 500 units

  • Purpose

    First aid antibiotic

  • Uses

     First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites

    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

    In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • clean the 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 20 - 25C (68 - 77F)

  • Inactive ingredients

    light mineral oil, white petrolatum

  • Package label

    image of carton label

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0031
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0031-11 in 1 CARTON
    128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/02/2013
    Labeler - Promex, LLC (789974388)
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