Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, 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 9, 2016

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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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