Label: TRIPLE ANTIBIOTIC- polymyxin b sulfate,neomycin sulfate,bacitracin zinc,lidocaine hydrochloride 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 November 18, 2021

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  • ACTIVE INGREDIENT

    POLYMYXIN B SULFATE;
    NEOMYCIN SULFATE;
    BACITRACIN ZINC;
    LIDOCAINE HYDROCHLORIDE

  • PURPOSE

    First aid antibiotic
    External analgesic

  • INDICATIONS & USAGE

    first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
    • cuts
    • scrapes
    • 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 DOCTOR

    • deep or puncture wounds
    • animal bites
    • serious burns

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    • adults and children 2 years of age or older:
    • 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 thearea 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    store at 10°C-30°C

  • INACTIVE INGREDIENT

    petrolatum

  • PRINCIPAL DISPLAY PANEL

    NDC: 82199-531-13 14.2 g in 1 TUBE

    14.2g label

    NDC: 82199-531-14 28.3 g in 1 TUBE

    28.3g label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    polymyxin b sulfate,neomycin sulfate,bacitracin zinc,lidocaine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82199-531
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82199-531-1314.2 g in 1 TUBE; Type 0: Not a Combination Product11/18/2021
    2NDC:82199-531-1428.3 g in 1 TUBE; Type 0: Not a Combination Product11/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/18/2021
    Labeler - Shandong Ruian Pharmaceutical Co.,Ltd. (723845363)
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