Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment

  • NDC Code(s): 67777-217-01, 67777-217-02, 67777-217-05, 67777-217-07, view more
    67777-217-10, 67777-217-11, 67777-217-12, 67777-217-13, 67777-217-14, 67777-217-15, 67777-217-16, 67777-217-17
  • Packager: Dynarex Corporation
  • 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 January 17, 2023

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  • Active Ingredient

    Bacitracin Zinc 400 Units First Aid Antibiotic

    Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin) First Aid Antibiotic
    Polymyxin B Sulfate 5000 Units First Aid Antibiotic

  • Purpose

    First Aid Antibiotic

  • Use(s)

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

  • Warnings

    For External Use Only

    Do not use

    • In the eyes or apply 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 out of reach of children

    If swallowed, get medical help or contact 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 between 15º-30ºC (59º-86ºF)

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

  • Inactive Ingedient

    White Petrolatum

  • Questions?

    1-888-396-2739 Monday - Friday 9AM - 5PM EST

  • Label

    1182 BX GVIN010Triple Antibiotic

  • Label

    1182 BX MASTERTriple Antibiotic

  • Label

    1182 BX SANY030Triple Antibiotic

  • Label

    1180 BX MASTERTriple Antibiotic

  • Label

    1185 BX MASTERTriple Antibiotic

  • Label

    1184 BX MASTERTriple Antibiotic

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
    bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-217-1172 in 1 CASE12/01/2009
    1NDC:67777-217-101 in 1 BOX
    1NDC:67777-217-0128.35 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67777-217-1372 in 1 CASE12/01/2009
    2NDC:67777-217-121 in 1 BOX
    2NDC:67777-217-0214.17 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-217-171728 in 1 CASE12/01/2009
    3NDC:67777-217-16144 in 1 BOX
    3NDC:67777-217-050.5 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:67777-217-151728 in 1 CASE12/01/2009
    4NDC:67777-217-14144 in 1 BOX
    4NDC:67777-217-070.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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