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

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TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]
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NDC 0924-5603-01, 0924-5603-03, 0924-5603-08, 0924-5603-09, 0924-5603-10, 0924-5603-11, 0924-5603-12
Set ID dea732fa-524b-4f75-bfee-285c30e74bdc
Category HUMAN OTC DRUG LABEL
Packager Acme United Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin zinc 400 units

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

    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 or apply 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 if you have

    • deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • condition persists or gets worse
    • A rash or other allergic reaction develops

    Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

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

    • Store at 15° to 25° C (59° to 77° F)
    • Do not use if packet is open or torn
  • Inactive ingredient

    Petrolatum

  • Questions? 1-800-835-2263

    Manufactured for:
    Acme United Corporation
    Fairfield, CT 06824

    REORDER
    www.PhysiciansCareFirstAid.com
    1 800 835 2263

  • Principal Display Panel - Packet Label

    FIRST AID ONLY®

    Triple
    Antibiotic

    Ointment

    NET WT 1/57 oz (0.5g)

    www.FirstAidOnly.com

    Fairfield, CT 06824

    1.800.835.2263

    © 2015 Acme United Corporation.

    Principal Display Panel - Packet Label
  • PRINCIPAL DISPLAY PANEL – 10 count box

    PhysiciansCARE

    Antibiotic
    Ointment

    Bacitracin zinc Neomycin sulfate Polymyxin B sulfate
    10 Single use Packets 0.5g each

    Reorder No. 12944

    ANSI Z308.1

    PRINCIPAL DISPLAY PANEL – 10 count box
  • PRINCIPAL DISPLAY PANEL – 12 count box

    12-001
    ANTISEPTICS

    FIRST AID ONLY®

    Triple Antibiotic Ointment

    12 (0.5g) Packets

    Pomada con triple antibiótico

    12 sobres de (0.5g)

    PRINCIPAL DISPLAY PANEL – 12 count box
  • 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 - UNII:58H6RWO52I) bacitracin400 [iU]  in 1 g
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin3.5 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:0924-5603-0310 in 1 BOX
    1NDC:0924-5603-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5603-0810 in 1 BOX
    2NDC:0924-5603-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5603-0912 in 1 BOX
    3NDC:0924-5603-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5603-1060 in 1 BOX
    4NDC:0924-5603-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5603-11144 in 1 BOX
    5NDC:0924-5603-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5603-1225 in 1 BOX
    6NDC:0924-5603-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/21/2012
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0924-5603)
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