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
  • 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 November 21, 2022

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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 finalpart333B11/24/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-477)
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