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

Drug Label Information

Updated November 17, 2023

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  • 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 DrugM00403/04/2022
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co. Ltd858030888manufacture(68001-531)
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