BACITRACIN OINTMENT [DIRECT RX]

BACITRACIN OINTMENT [DIRECT RX]
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NDC 61919-116-30
Set ID 4bb5152e-c79a-35de-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager DIRECT RX
Generic Name
Product Class
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Bacitracin 500 units

  • PURPOSE

    First aid antibiotic

  • WHEN USING

    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. (1-800-222-1222)

  • QUESTIONS

    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

  • ASK DOCTOR

    store at 20°-25°C (68°-77°F)

  • DOSAGE & ADMINISTRATION

    na

  • INACTIVE INGREDIENT

    na

  • INDICATIONS & USAGE

    na

  • KEEP OUT OF REACH OF CHILDREN

    na

  • PRINCIPAL DISPLAY PANEL

    116

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-116(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:61919-116-301 g in 1 CARTON; Type 0: Not a Combination Product03/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/27/2017
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-116)

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