TRIPLE ANTIBIOTIC OINTMENT (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [NEOPHARM CO., LTD]

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TRIPLE ANTIBIOTIC OINTMENT (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [NEOPHARM CO., LTD]
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NDC 51141-0070-1, 51141-0070-3, 51141-0070-5
Set ID 7b7ecb27-8414-4933-bc13-405ef9032167
Category HUMAN OTC DRUG LABEL
Packager NeoPharm Co., Ltd
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • Active ingredient

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5mg

    Polymyxin B Sulfate 5,000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only
    Do not use if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    • serious burns
    • deep or puncture wounds
    • animal bites

    When using this product

    • do not use in the eyes
    • do not apply over large areas of the body

    Stop use and ask a doctor if

    • you need to use more than 1 week
    • condition persists or gets worse
    • symptoms persist for more than 1 week or clear up and occur again within a few days.
    • 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

    • adults and children 2 years of age or older:
      • clean the affected area
      • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
      • may be covered with a sterile bandage
    • children under 2 years of age:  ask a doctor
  • Other information

    • store at 59° to 77°F

  • Inactive ingredients

    Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

  • Package label panel

    Triple Antibiotic Ointmentimage of a carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC OINTMENT 
    bacitracin zinc, neomycin sulfate, polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARETH-2 (UNII: V56DFE46J5)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0070-11 in 1 BOX
    128 g in 1 TUBE
    2NDC:51141-0070-51 in 1 BOX
    214 g in 1 TUBE
    3NDC:51141-0070-31 in 1 BOX
    39.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/01/2010
    Labeler - NeoPharm Co., Ltd (631101883)
    Registrant - NeoPharm Co., Ltd (631101883)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd631101883manufacture
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