Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b 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 August 3, 2022

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  • • ACTIVE INGREDIENT

    Bacitracin zinc 400 units

    Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base)

    Polymyxin - B sulfate 5000 units

    Active ingredient (in each gram)Purpose
    Bacitracin Zinc 400 UnitsFirst Aid Antibiotic
    Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base)First Aid Antibiotic
    Polymyxin B Sulfate 5000 UnitsFirst Aid Antibiotic
  • • USES

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • 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 •on deep lacerations or puncture wounds, animal bites, or serious burns

    STOP USE AND ASK A DOCTOR IF

    •condition persists or gets worse •a rash or allergic reaction occurs

    •condition persists for more than 7 days

    Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    Adults and Children Clean the affected area. Apply a small amount of product

    (equal to the surface area of a fingertip) 1 to 3 times daily. May be covered with a sterile bandage.

  • OTHER INFORMATION

    Store at 15°- 30°C (59°- 86°F)

  • INACTIVE INGREDIENT

    White Petrolatum

  • QUESTIONS

    Questions 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Carton Image Carton Image

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5610(NDC:50382-023)
    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) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5610-0225 in 1 CARTON08/05/2022
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5610-000.5 g in 1 PACKET; Type 0: Not a Combination Product08/05/2022
    3NDC:0924-5610-0112 in 1 CARTON08/05/2022
    30.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/04/2022
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339repack(0924-5610) , relabel(0924-5610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599repack(0924-5610) , relabel(0924-5610)
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