Label: TRIPLE ANTIBIOTIC- polymyxin b sulfate,neomycin sulfate,bacitracin 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 13, 2021

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  • WARNINGS

    For external use only.

  • INACTIVE INGREDIENT

    white petrolatum

  • DO NOT USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    First aid antibiotic
    External analgesic

  • ASK DOCTOR

    • deep or puncture wounds
    • animal bites
    • serious burns

  • ACTIVE INGREDIENT

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

  • OTHER SAFETY INFORMATION

    store at 10-30°C

  • 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 the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: ask a doctor

  • INDICATIONS & USAGE

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

  • PRINCIPAL DISPLAY PANEL

    NDC:82199-530-12 28.3 g in 1 TUBE

    28.3 g label

    NDC:82199-530-11 14.2 g in 1 TUBE

    14.2g label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    polymyxin b sulfate,neomycin sulfate,bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82199-530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3500 [USP'U]  in 1 g
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Coloryellow (YELLOW (Translucent)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82199-530-1114.2 g in 1 TUBE; Type 0: Not a Combination Product08/26/2021
    2NDC:82199-530-1228.3 g in 1 TUBE; Type 0: Not a Combination Product08/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/26/2021
    Labeler - Shandong Ruian Pharmaceutical Co.,Ltd. (723845363)
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