Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2011

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  • 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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