Label: BACITRACIN ZINC- first aid antibiotic ointment

  • NDC Code(s): 68001-531-45, 68001-531-46
  • Packager: BluePoint Laboratories
  • 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 24, 2022

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

  • Active Ingredient

    Bacitracin Zinc (500 units in each gram)

  • Purpose

    First Aid Antibiotic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only

    Do not use

    • In the eyes or apply over large areas of the body
    • If you are allergic to any of the ingredients
    • Longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    the condition persists or gets worse

    if a rash or other allergic reaction develops

    Keep out of 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

    • Do not use if seal on the tube is damaged or is not visible
    • To open,unscrew cap, pull tab to remove foil seal
    • Store at room temperature
    • Avoid excessive heat and humidity
    • Preserve in well-closed container
    • See crimp of tube or carton for Lot Number and Expiry Date
  • Inactive Ingredients

    Mineral Oil, Paraffin, White Petrolatum

  • Questions?

    Contact 1-800-707-4621

    Manufactured in India by:

    Gopaldas Visram & Company Limited

    Plot No. A327, T.T.C Indl. Area, M.I.D.C

    Mahape, Navi Mumbai - 400710.

    Mfg. Lic. No.: KD/503

    For BluePoint Laboratories

    Rev 02/2022

  • 0.5oz Label

    0.5 oz label

  • 0.5oz Carton

    0.5oz Carton

  • 1oz Label

    1oz Label

  • 1oz Carton

    1oz Carton

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-531
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-531-451 in 1 CARTON03/04/2022
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68001-531-461 in 1 CARTON03/04/2022
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/04/2022
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co. Ltd858030888manufacture(68001-531)