Label: BACITRACIN ZINC 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 October 9, 2018

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

  • Drug Facts

  • Active ingredient (in each gram)

    Bacitracin zinc. USP 500 units

  • Purpose

    First aid antibiotic

  • Uses

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

  • Warnings

    For external use only

    Allergy alert: • do not use if allergic to any of the ingredients

    Do not use • 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

    When using this product • do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if • condition persists or gets worse • a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

  • Inactive ingredient

    white petroleum Jelly

  • Other information

    • Store at room temperature 59°-77°F (15°-25°C)

    • Before using any medication, read all label directions. Keep carton, it contains important information.

  • Questions?

    1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

  • SPL UNCLASSIFIED SECTION

    Prevents Infection in Minor Cuts, Scrapes and Burns

    This product is not manufactured or distributed by Johnson & Johnson Consumer Companies, Inc.. owner of the registered trademark Neosporin®

    Distributed by:

    Delsam Pharma Llc

    Bronx, Newyork 10467.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-108
    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
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-108-301 in 1 CARTON09/25/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/25/2018
    Labeler - Delsam Pharma Llc (081369679)