Label: UEC MEDICAL FIRST AID ANTIBIOTIC- bacitracin zinc 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 April 5, 2018

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Bacitracin zinc (equal to Bacitracin 500 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

    • 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
  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a 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 hard paraffin, liquid paraffin, white soft paraffin

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UEC Medical

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    10390

  • PRINCIPAL DISPLAY PANEL

    10394

  • INGREDIENTS AND APPEARANCE
    UEC MEDICAL FIRST AID ANTIBIOTIC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-390-2020 in 1 BOX04/04/2016
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:65923-390-44144 in 1 BOX04/04/2016
    20.9 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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