BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]
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NDC 67777-240-01, 67777-240-02
Set ID 650d1b78-005c-41eb-9df4-67a5d576c02b
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredient (in ea. gram)                                                Purpose           
    Bacitracin Zinc 400 Units                                                                      antibacterial

    Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)                         antibacterial

    Polymyxin B Sulfate 5000 Units                                                            antibacterial

  • Uses triple antibiotic :

    First aid to help prevent infection in:
    • Minor cuts
    • scrapes
    • burns
  • Ask a doctor before use:

    • in case of deep or puncture wounds
    • animal bites
    • serious burns

  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
    • avoid excessive heat and humidity
    • Tamper Evident. Do not use if packet is torn, cut or open.
  • Inactive ingredients:

    White petrolatum

  • Directions triple antibiotic:

    •  clean affected areas
    •  apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • 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.

  • INDICATIONS & USAGE

    First aid antibacterial ointment to help prevent infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only

  • Principal Display Panel

    Triple Antibiotic

    triple_antibiotic

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
    bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-240-0112 in 1 CASE
    1144 in 1 BOX
    10.5 g in 1 PACKET
    2NDC:67777-240-0212 in 1 CASE
    2144 in 1 BOX
    20.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/16/2011
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)

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