Label: FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine 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 September 15, 2010

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  • SPL UNCLASSIFIED SECTION

    FIRST AID
    TRIPLE ANTIBIOTIC
    With PAIN RELIEVER

  • Active ingredients (in each gram)

    Bacitracin zinc (400 units bacitracin

    Neomycin sulfate (3.5 mg neomycin)

    Polymyxin B sulfate (5000 units)

    Lidocaine 40mg

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    First Aid Antibiotic

    Anesthetic

  • INDICATIONS & USAGE

    Uses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes and burns.

  • Warnings

    For external use only

  • Do not use

    • in eyes
    • over large areas of the body
    • in case of deep or puncture wounds, animal bites or serious burns
    • if allergic to ingredients
    • longer than 1 week unless directed by a doctor
  • STOP USE

    Stop use and ask a doctor if condition gets worse or a rash or other allergic reactions occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children If ingested, contact a Poison Control Center right away.

  • Directions

    • Adults and children 2yrs. And older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily, may cover with a sterile bandage
    • Children under 2: Ask a Doctor
  • Inactive ingredients

    petrolatum

  • PRINCIPLE DISPLAY PANEL

    SUPER
    BIOTIC
    WOUND OINTMENT

    #100210

    FIRST AID
    TRIPLE ANTIBIOTIC
    WITH PAIN RELIEVER

    0.7g (1/41 oz.)

    Mfd for FAD
    First Aid Direct
    Mason, OH 45040

    Active ingredients (in each gram)
    Bacitracin zinc (400 units Bacitracin)
    Neomycin sulfate (3.5 mg neomycin)
    Polymyxin B sulfate (5000 units)
    Lidocaine 40 mg

    Purpose
    First Aid Antibiotic
    First Aid Antibiotic
    First Aid Antibiotic
    Anesthetic

    Uses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes, and burns

    PRINCIPLE DISPLAY PANEL - SUPER BIOTIC WOUND OINTMENT
  • INGREDIENTS AND APPEARANCE
    FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-6500
    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
    lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68421-6500-00.7 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/30/2007
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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