Label: TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

  • NDC Code(s): 67234-031-01, 67234-031-02
  • Packager: Natureplex LLC
  • 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 September 28, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients(in each gram)Purpose
    Bacitracin zinc 400 unitsFirst aid antibiotic
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 5,000 unitsFirst aid antibiotic
  • Use

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

  • Warnings

    For external use only.

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of a finger tip) on the area up to 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING
  • Inactive ingredient

    petrolatum

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 28g Tube Carton

    BACITRACIN

    NEOMYCIN

    POLYMYXIN

    Natureplex™
    Triple Antibiotic
    ORIGINAL OINTMENT

    NET WT 1 Oz (28g)

    PRINCIPAL DISPLAY PANEL - 28g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC   FIRST AID ANTIBIOTIC
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 9.4 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 9.4 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 9.4 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-031-011 in 1 CARTON08/03/2011
    19.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67234-031-021 in 1 CARTON09/27/2021
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B08/03/2011
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-031)
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