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 August 29, 2014

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  • Active ingredient

    (in each gram)

    Bacitracin zinc (400 units bacitracin)

    Neomycin sulfate (3.5 mg neomycin)

    Polymyxin B sulfate (5000 units)

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    First Aid Antibiotic

  • Use

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

  • Warnings

    For external use only

    Do not use

    • in eyes
    • over large areas of the body or on puncture wounds, animal bites or serious burns
    • for more than 1 week unless directed by a doctor
    • if you are allergic to any of the ingredients

    Stop use and ask a doctor if

    • a rash or allergic reaction develops
    • condition worsens or persists

    Keep out of reach of children

    If ingested, contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply a small amount 1 to 3 times daily
    • may cover with a sterile bandage
  • Inactive ingredients

    petrolatum

  • Principal Display Panel - 0.5g Packet Label

    TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

    ointment

    Helps Prevent Infection in Cuts and Scrapes

    TRIPLE ANTIBIOTIC

    0.5g

    The Provision First Aid LineTM

    Principal Display Panel - 0.5g Packet Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin400 [USP'U]  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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-5005-10.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/29/2014
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-5005)
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