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 28, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    (Each gram contains)

    Bacitracin 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 and scrapes
    • Minor burns
  • Warnings:

    For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

    Keep out of the reach of children.

    STOP USE AND ASK A DOCTOR IF:

    • Conditions worsen or clear up and then recur
    • The condition persists for more than 7 days
    • A rash or allergic reaction occurs

    DO NOT USE:

    • In the eyes
    • Over large areas of the body
    • If you are allergic to any of the ingredients
    • Longer than 1 week unless directed by a doctor
    • On raw surfaces, blistered areas or serious burns
    • For deep lacerations or puncture wounds

    WHEN USING THIS PRODUCT:

    • Avoid contact with the eyes or mucus membranes
  • Directions:

    Tamper evident packaging, do not use if packet is opened or torn.

    Adults and children:

    Clean the affected area, apply a small amount of this product (equal to the surface area of a fingertip) 1 to 3 times daily

  • Other information:

    Store at room temperature

  • Inactive ingredients:

    Petrolatum

  • Questions about this product: Call 1-800-835-2263 with any questions about this product.

  • 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 – 12 count box

    PAC-KIT FIRST AID

    UNIT
    12-001

    12 EACH

    Triple Antibiotic
    Ointment Packets

    Contains 12 ea. First Aid Antibiotic ointment packets
    (min. weight each, 0.5 gm) to help prevent infection in minor cuts,
    scrapes and burns. See back panel for Drug Facts listing.

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

    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 zinc - UNII:89Y4M234ES) bacitracin zinc400 [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 b sulfate5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5603-0412 in 1 BOX
    1NDC:0924-5603-010.5 g in 1 PACKET
    2NDC:0924-5603-0525 in 1 BOX
    2NDC:0924-5603-010.5 g in 1 PACKET
    3NDC:0924-5603-0660 in 1 BOX
    3NDC:0924-5603-010.5 g in 1 PACKET
    4NDC:0924-5603-07144 in 1 BOX
    4NDC:0924-5603-010.5 g in 1 PACKET
    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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