Label: UEC MEDICAL FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

  • Category: HUMAN OTC DRUG LABEL

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 April 6, 2018

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Bacitracin zinc 400 units..............................................................First aid antibiotic

    Neomycin sulfate 5 mg (equivalent to 3.5 mg Neomycin)............First aid antibiotic

    Polymyxin B sulfate 5,000 units...................................................First aid antibiotic

  • PURPOSE

    Uses

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • 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 be covered with a sterile bandage
  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25°C (59° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    white soft paraffin

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UEC Medical

    17211 Valley View Ave.

    Cerritos, CA 90703

  • PRINCIPAL DISPLAY PANEL

    10391

  • PRINCIPAL DISPLAY PANEL

    10395

  • PRINCIPAL DISPLAY PANEL

    10392

  • PRINCIPAL DISPLAY PANEL

    10396

  • INGREDIENTS AND APPEARANCE
    UEC MEDICAL FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-391
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-391-2020 in 1 BOX04/04/2016
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:65923-391-44144 in 1 BOX04/04/2016
    20.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:65923-391-2120 in 1 BOX04/04/2016
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:65923-391-45144 in 1 BOX04/04/2016
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/04/2016
    Labeler - United Exchange Corp. (840130579)
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