Label: BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE 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 October 12, 2022

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  • Active Ingredient

    Bacitracin Zinc (400 units)

    Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin)

    Polymyxin B Sulfate 5000 Units

  • Purpose

    First Aid Antibiotic

  • Use(s)

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

  • Warnings

    For External Use Only

    Do not use

    • In the eyes or 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 if you have

    Deep or puncture wounds, animal bites, or serious burns.

    Stop use and ask a doctor if

    • The condition persists or gets worse

    • A rash or other allergic reaction develops

    Keep our of reach of children

    If swallowed, get medical help or contract a Poison Control Center (1-800-222-1222) right away.

  • 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 15º-30ºC (59º-86ºF)

    • Tamper evident. Do not use if seal if torn, cut, or opened.

  • Inactive Ingredients

    White Petrolatum

  • Label

    HS-570-3130 BX MASTER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE 
    bacitracin zinc, polymyxin b sulfate, and neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B50000 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0171-5072 in 1 CASE11/04/2022
    11 in 1 BOX
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/04/2022
    Labeler - Henry Schein (012430880)
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