Label: DRS. ANTIBIOTIC BACITRACIN- bacitracin ointment

  • NDC Code(s): 80489-006-01, 80489-006-02
  • Packager: OL PHARMA TECH, LLC
  • 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 2, 2023

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

View All Sections
  • Active ingredient

    Bacitracin zinc 500 units in one gram

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in :

    • minor cuts
    • burns
    • scrapes
  • 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 a doctor before use

    Ask a doctor before use

    on deep or puncture wounds, animal bites, or serious burns

    Stop use

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or other allergic reaction develops

  • Directions

    Directions

    • clean the affected area and dry thoroughly
    • 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

  • Storage and Handling

    • store at room temperature
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    Petrolatum

  • keep out of reach of children

    If swallowed get medical help or contact a poison control center right away

  • Questions

    www.drspharmacyusa.com

  • PRINCIPAL DISPLAY PANEL

    Antibiotic ointmentDrs. Bacitracin Antibiotic ointment

  • INGREDIENTS AND APPEARANCE
    DRS. ANTIBIOTIC BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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:80489-006-011 in 1 CARTON10/01/2021
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80489-006-021 in 1 CARTON10/01/2021
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/01/2021
    Labeler - OL PHARMA TECH, LLC (021170377)
    Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH, LLC Drs PHARMACY021170377manufacture(80489-006)
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!