UEC MEDICAL FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [UNITED EXCHANGE CORP.]

UEC MEDICAL FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [UNITED EXCHANGE CORP.]
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NDC 65923-391-20, 65923-391-21, 65923-391-44, 65923-391-45
Set ID 69237c1b-4a71-8f93-e053-2991aa0a1b02
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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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