BACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]

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BACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]
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NDC 42254-031-15
Set ID fea57e0a-c472-4c83-9afd-6765a16600b9
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Active ingredient (each gram contains)

    Bacitracin 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
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • 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 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°-25°C (68°-77°F)
  • Inactive ingredients

    light mineral oil, white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Bacitracin 500 Units

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-031(NDC:45802-060)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-031-15144 in 1 CARTON
    10.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/20/2011
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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