TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B) OINTMENT [ADVANCED FIRST AID, INC.]

TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B) OINTMENT [ADVANCED FIRST AID, INC.]
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NDC 67060-360-09, 67060-360-28, 67060-360-39, 67060-360-47
Set ID 5c8adcb7-b9b5-437c-bc4d-3a568ef9d4e5
Category HUMAN OTC DRUG LABEL
Packager ADVANCED FIRST AID, INC.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (equivalent to 3.5 mg. Neomycin)

    Polymyxin B Sulfate 5000 units

  • PURPOSE

    first aid antibiotic

  • INDICATIONS & USAGE

    Uses:

    First aid to help prevent infection in: • minor cuts • burns • scrapes

  • WARNINGS

    Warnings:

    • For external use only

    Do not use:

    • in the eyes • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock • over large areas of the body • longer than 1 week unless directed by a doctor

    Stop use and ask a doctor:

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

    • if the condition persists or gets worse

    • if a rash or other allergic reaction develops

  • 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.

  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: petrolatum.

  • PRINCIPAL DISPLAY PANEL

    Tripleadvcarton

  • PRINCIPAL DISPLAY PANEL

    tripleadvtube

  • PRINCIPAL DISPLAY PANEL

    tripleadvpacket

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin, neomycin, polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-360
    Route of Administrationtopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-360-3925 in 1 CARTON04/08/201510/17/2016
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67060-360-2828 g in 1 TUBE; Type 0: Not a Combination Product10/17/2016
    3NDC:67060-360-47144 in 1 CARTON10/17/2016
    3NDC:67060-360-090.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/08/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(67060-360)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-360)

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