Label: BACITRACIN ointment

  • NDC Code(s): 68001-477-45, 68001-477-46, 68001-477-47, 68001-477-48
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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  • Drug Facts

  • Active ingredient

    Bacitracin (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 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, or if a rash or other allergic reaction develops.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Centre 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
    • 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 09/2021

  • Principal Display Panel

    Bacitracin sachet and carton 0.9g

    0.9 sachet0.9 carton

  • PRINCIPAL DISPLAY PANEL

    Bacitracin tube and carton 14.2g

    14g tube14g carton

  • PRINCIPAL DISPLAY PANEL

    Bacitracin 28.4g tube and carton

    28g tube 28g carton

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-477
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  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:68001-477-481 in 1 CARTON11/24/2020
    1NDC:68001-477-450.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68001-477-461 in 1 CARTON11/24/2020
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68001-477-471 in 1 CARTON11/24/2020
    328.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00411/24/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-477)
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