Label: 0.9G TRIPLE ANTIBIOTIC- bacitracin zinc 400 units ointment

  • 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

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  • Active Ingredient

    (in each gram)

    Bacitracin Zinc (bacitracin 400 units)

    Neoycin sulfate (neoycin 3.5 mg)

    Polymyxin B sulfate

    (polymyxin B 5,000 units)

    Purpose

    Bacitracin Zinc 400 units........First aid antibiotic

  • USE

    First aid to help prevent infection in

    minor cuts
    scrapes
    burns

  • Warning

    For external use only.

    Do not use

    in the eyes
    over large areas of the body
    if you are allergic to any of the ingredients
    longer than 1 week unless directed by doctor

  • ASK DOCTOR

    Ask a doctor before use if

    on deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask doctor if

    condition persists or gets worse
    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

  • STORAGE AND HANDLING

    Store at room temperature

  • Inactive ingredients

    Mineral oil, Petrolatum, Purified water

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    0.9G TRIPLE ANTIBIOTIC 
    bacitracin zinc 400 units ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-128-011 in 1 PACKAGE03/24/2022
    10.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/24/2022
    Labeler - Sled Distribution, LLC (079772888)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sled Distribution, LLC079772888manufacture(81417-128)
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