TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [UNIFIRST FIRST AID CORPORATION]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-223-12, 47682-223-35, 47682-223-73, 47682-223-99
Set ID d265f094-e654-4c68-9215-b5d061af885d
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (each gram contains)

    Bacitracin zinc (400 units)

    Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin)

    Polymyxin-B sulfate 5000 units

  • Purpose

    First Aid Antibiotics

  • 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
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use

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

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep out of reach of children.

    If swallowed, get medical help 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 room temperature 15° to 30°C (59° to 86°F) (do not freeze)
    • tamper evident. Do not use if packet is torn, cut or opened.
    • avoid excessive heat and humidity
  • Inactive ingredients

    white petrolatum

  • Questions or comments?

    1-800-634-7680

  • Medi-First Triple Antibiotic Ointment Label

    Medi-First®

    Triple Antibiotic Ointment

    Bacitracin Zinc / Neomycin Sulfate / Polymycin B Sulfate

    First Aid Antibiotic

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

    0.5g (1/57oz) Packets / 25 per box

    MF Triple Antibiotic Safetec label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-223-1210 in 1 BOX04/25/2013
    1NDC:47682-223-990.5 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:47682-223-7325 in 1 BOX04/25/2013
    2NDC:47682-223-990.5 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:47682-223-35144 in 1 BOX04/25/2013
    3NDC:47682-223-990.5 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:47682-223-990.5 g in 1 POUCH; Type 0: Not a Combination Product04/25/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/25/2013
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(47682-223)