Label: ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate 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 28, 2022

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc, USP 500 units
    Polymyxin B sulfate, USP 10,000 units

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in

    • 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

    • 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
    • a rash or other allergic reaction develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • clean 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 15º-25ºC (59º-77ºF)
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredient

    white petrolatum

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    Compare to the active ingredients in Polysporin®*

    DOUBLE ANTIBIOTIC OINTMENT

    BACITRACIN ZINC

    POLYMYXIN B SULFATE OINTMENT, USP

    FIRST AID ANTIBIOTIC

    FOR EXTERNAL USE ONLY

    HELPS PREVENT INFECTION

    IN MINOR CUTS,

    SCRAPES, AND BURNS

    *This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Polysporin®.

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE,

    CAMP HILL, PA 17011

    www.riteaid.com

  • Package label

    Bacitracin Zinc, USP 500 units, Polymyxin B Sulfate, USP 10,000 units

    RITE AID Double Antibiotic Ointment

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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:11822-0044-51 in 1 CARTON02/25/2022
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/25/2022
    Labeler - Rite Aid Corporation (014578892)
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