TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]
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NDC 0924-5603-01, 0924-5603-02
Set ID fe15585f-147b-4e14-9ba3-7c5a1a9a7e74
Category HUMAN OTC DRUG LABEL
Packager Acme United Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin Zinc (400 units Bacitracin)

    Neomycin Sulfate 3.5 mg

    Polymyxin-B Sulfate 5000 units

  • Purpose

    First Aid Antibiotics

  • Uses

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

  • Warnings

    For external use only

    Do not use

    • in eyes
    • internally
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • for more than 1 week unless directed by a doctor

    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 right away

  • Directions

    Adults and children 2 years and over:

    • 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 cover with a sterile bandage

    Children under 2 years:

    • consult a doctor

    Other information

    • store at room temperature (do not freeze)
    • do not use any opened or torn packets
  • Inactive ingredients

    petrolatum

  • PRINCIPAL DISPLAY PANEL – packet

    NDC 0924-5603-01

    PhysiciansCARE

    Triple Antibiotic
    Ointment

    0.5 g (1/57 oz.)

    Acme United Corporation

    Fairfield, CT 06824 800-835-2263

    PRINCIPAL DISPLAY PANEL – packet
  • PRINCIPAL DISPLAY PANEL – bag

    UNIT
    12-001B

    PAC-KIT FIRST AID

    Triple Antibiotic
    Ointment Packets

    ANSI Z308.1-2003R
    Contents: 6 Single Use Packets
    0.5 gr. (1/57 fl. oz.)
    See reverse for Drug Facts

    Distributed by Acme United Corporation
    Fairfield, CT 06824 · 800-835-2263

    PRINCIPAL DISPLAY PANEL – bag
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5603
    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:0924-5603-026 in 1 BAG
    1NDC:0924-5603-010.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/27/2012
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE

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