Label: POLY BACITRACIN- first aid antibiotic ointment 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 March 6, 2019

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

  • Active Ingredient

    Bacitracin zinc 500 units (in one gram)

  • Purpose

    First Aid Antibiotic

  • Active Ingredients

    Polymyxin B sulfate 10,000 units (in one gram)

  • Purpose

    First Aid Antibiotic

  • Uses

    first aid to help prevent infection in minor: cuts, scrapes, burns

  • Warnings

    For external use only

    Do not use

    in the eyes, over large areas of the body, if you are allergic to any of the ingredients, longer than one week

    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 one week, condition persists or gets worse, rash or other allergic reaction develops

    If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

  • 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

  • Other Information

    store at room temperature

  • Inactive Ingredients

    white petrolatum

  • Questions and comments?

    1-888-396-2739

  • Label

    CR-1164 Poly Bacitracin Primary Display Panel

  • INGREDIENTS AND APPEARANCE
    POLY BACITRACIN 
    first aid antibiotic ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0471
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0471-172 in 1 CASE11/20/2018
    11 in 1 BOX
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/20/2018
    Labeler - Cardinal Health (097537435)
    Registrant - Dynarex Corporation (008124539)