Label: OLP TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine 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 26, 2018

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  • Active ingredients

    Bacitracin zinc 400 units
    Neomycin 3.5 mg
    Polymyxin B sulfate 5,000 units

    Pramoxine hydrochloride 10 mg

  • USES

    first aid to help prevent infection in minor
    • cuts
    • scrapes
    • burns

  • Purpose

    • first aid antibiotic
    • External Analgesic
  • Warnings

    For external use only

  • Do not use

    Do not use
    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

  • ASK DOCTOR

    Ask a doctor before use if you have
    • deep or puncture wounds
    • animal bites
    • serious burns

  • STOP USE

    Stop use and ask a doctor if
    • the condition persists or gets worse
    • a 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.

  • Directions

    • 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

  • Other information

    Store at room temperature

  • Inactive ingredient

    Petrolatum

  • Questions

    www.ohiolabpharma.us

  • PRINCIPAL DISPLAY PANEL

    triple antibiotic plus pain relief

    Net Weight 0.33 oz (9.4g0

    NDC#70648-121-01

  • INGREDIENTS AND APPEARANCE
    OLP TRIPLE ANTIBIOTIC PLUS 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70648-121-011 in 1 CARTON12/06/2017
    19.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/06/2017
    Labeler - Ohio Lab Pharma (080215854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohio Lab Pharma080215854manufacture(70648-121)
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