Label: TRIPLE ANTIBIOTIC- first aid antibiotic ointment

  • NDC Code(s): 68001-483-45, 68001-483-46
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Bacitracin Zinc (400 units in each gram)

    Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

    Polymyxin B Sulfate (5000 units per gram)

  • Purpose

    First Aid Antibiotics

  • Uses

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

  • Warnings

    For external use only.

  • Do not use

    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

  • WHEN USING

    Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor ifthe condition persists or gets worse, or if a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    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 temperatue
    • Preserve in well-closed containers
    • See crimp of tube or carton for Lot Number and Expiry Date

  • Inactive ingredients

    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.L.D.C.

    Mahape, Navi Mumbai - 400710.

    Mfg. Lic. No.: KD/503

    For BluePoint Laboratories

    Rev 09/2021

  • Package Label - Principal Display Panel

    tube 0.5Triple Antibiotic Ointment 0.5 oz NDC: 68001-483-46

    0.5 carton

    1 oz tube 1oz cartonTriple Antibiotic Ointment 1 oz 68001-483-45

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-483
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-483-461 in 1 CARTON06/15/2021
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68001-483-451 in 1 CARTON06/15/2021
    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 DrugM00406/15/2021
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co Ltd858030888manufacture(68001-483)
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