Label: MEDI-FIRST- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 71927-017-01, 71927-017-02
  • Packager: Orazen Inc
  • 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 February 17, 2023

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  • Active ingredients

    (in each gram)

    Bacitracin zinc 400 units

    Neoycin sulfate equivalent to 3.5 mg of neomycin base

    Polymyxin B sulfate 5,000 units

  • Purpose

    First Aid antibiotic

    First Aid antibiotic

    First Aid antibiotic

  • Uses

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

  • Warning

    For external use only.

  • DO NOT USE

    Do not use

    • in the eyes
    • internally
    • 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 a doctor before use

    • in case of deep 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.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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
  • Other information

    • store at room temperature (59°-86°F) (do not freeze)
    • tamper evident. Do not use if packet is torn, cut or opened.
  • Inactive ingredients

    mineral oil, petrolatum, water

  • Questions or comments?

    1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    image of pouch labelimage of box label

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-017
    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) NEOMYCIN0.0035 g  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-017-0225 in 1 BOX02/17/2023
    1NDC:71927-017-010.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/17/2023
    Labeler - Orazen Inc (080916640)
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