Label: BACITRACIN ZINC ointment

  • NDC Code(s): 57896-111-09, 57896-111-14
  • Packager: GERI-CARE PHARMACEUTICAL CORP
  • 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 May 26, 2020

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

  • Active ingredient (in each gram)

    Bacitracin Zinc 500 units

  • 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
    • if you are allergic to any of the ingredients
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

  • Ask a doctor before use

    in case of deep or puncture wounds, animal bites, or serious burns.

  • Stop use and ask a doctor if

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • 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

  • Other information

    • Tamper Evident. Do not use if packet is torn, cut or opened.
    • Store at room temperature 15° to 30°C (59° to 86°F)
    • Avoid excessive heat and humidity

  • Inactive Ingredients

    mineral oil and white petrolatum

  • Questions and comments

    1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-111-14144 in 1 CARTON05/01/2020
    1NDC:57896-111-090.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/01/2020
    Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)