Label: ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine 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 February 17, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients (in each gram)

    Bacitracin Zinc 500units

    Neomycin 3.5mg

    Polymyxin B Sulfate 10,000 units

    Pramoxine HCl 10mg

    Purpose

    Active ingredients

    (each gram contains)     		Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
    Pramoxine HCI 10 mgExternal analgesic
  • Uses

    First aid to help prevent infection and provide 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 a doctor before use if you have

    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
    • condition persists for more than 1 week, or clear up and occur again within a few days
    • 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

    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 1 to 3 times daily
    • may be covered with a sterile bandage

    children under 2 years of age: consult a physician

  • Other information

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    petrolatum

  • PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Ointment + Pain Relief

    Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

    First Aid Antibiotic Ointment

    Maximum Strength

    NET WT 1 oz (28.3 g)

    carton

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0682-11 in 1 CARTON02/17/2020
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/17/2020
    Labeler - Kareway Product, Inc. (121840057)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!