GENUINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE) OINTMENT [YUYAO JESSIE COMMODITY CO.,LTD.]

GENUINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE) OINTMENT [YUYAO JESSIE COMMODITY CO.,LTD.]
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NDC 51414-903-01, 51414-903-02
Set ID 29d8fea0-374b-2b72-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Yuyao Jessie Commodity Co.,Ltd.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • Active Ingredient

    Bacitracin Zinc 400 units
    Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
    Polymyxin B Sulfate 5000 units

    Purpose

    Triple Antibiotic

  • Use

    to help prevent infection in minor cuts,scrapes and burns.

  • WARNINGS

    for external use only.

    Do not use:in eyes,over large areas of the body,if allergic to any of the ingredients,or for more than one week unless directed by a physician.

    Stop use and consult a doctor:if the 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 ingested,contact a poison control center right away.

  • Directions

  • Inactive ingredients

    Vaseline
    Mineral Oil
    Purified Water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-903-010.5 g in 1 PACKET; Type 0: Not a Combination Product01/05/2018
    2NDC:51414-903-020.9 g in 1 PACKET; Type 0: Not a Combination Product01/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/20/2016
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-903)

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