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 January 27, 2012

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  • 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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