Label: TRIPLE ANTIBIOTIC- polymyxin b sulfate, neomycin sulfate, bacitracin, 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 October 25, 2022

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  • ACTIVE INGREDIENT

    Polymyxin B sulfate 5000units

    Neomycin sulfate 3500units

    Bacitracin 500units

    Lidocaine hydrochloride 40mg

  • PURPOSE

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    External analgesic

  • INDICATIONS & USAGE

    First aid to help prevent infection and for the temporary relief of pain in minor:

    • cuts
    • scrapes
    • burns
    • surgical wound
  • 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
  • STOP USE

    • You need to use longer than 1 week
    • Condition persists or gets worse
    • Symptoms persist for more than 1 week, or clear up and occur again within a few days
    • 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.

  • DOSAGE & ADMINISTRATION

    • Adults and children 2 years of age and 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 2 to 4 times daily and 5 days as a course of treatment.

    • Children under 2 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    • Store at 10℃-30℃
  • INACTIVE INGREDIENT

    Light mineral oil

    White petrolatum

  • PRINCIPAL DISPLAY PANEL

    TRIPLE ANTIBIOTIC OINTMENT

    TRIPLE ANTIBIOTIC OINTMENT 1 oz (28.3g)

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    polymyxin b sulfate, neomycin sulfate, bacitracin, lidocaine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82695-0001
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Colorwhite (White to light yellow suspension) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82695-0001-328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/23/2022
    Labeler - Shandong Teking Pharmaceutical Co., Ltd (617652601)
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