FAMILY WELLNESS (NEOMYCIN, BACITRACIN, POLYMYXIN) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]

FAMILY WELLNESS (NEOMYCIN, BACITRACIN, POLYMYXIN) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]
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NDC 55621-009-01
Set ID d6f62235-4fa4-410c-9bd1-bb9569611a74
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Jingwei Pharmaceutical Co., Ltd.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • INACTIVE INGREDIENT

    Inactive Ingredients mineral oil, petrolatum

  • ACTIVE INGREDIENT

    Active Ingredient (in each gram)

    Bacitracin 400 units

    Neomycin 3.5 mg

    Polymyxcin B 5,000 units

  • PURPOSE

    Purpose

    First aid antibiotic

  • 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.

  • INDICATIONS & USAGE

    Uses first aid to help prevent infection in minor:

    -cuts

    -scrapes

    -burns

  • WARNINGS

    Warnings For external use only

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years of age and older:

    -clean the affected area

    -apply a small amount of this product to affected area 1 to 3 times daily

    -may be covered with a sterile bandage

    Children under 2 years of age: ask a doctor before use


  • STOP USE

    Stop use and ask a doctor if

    -symptoms last for more than 7 days, the condition persists or gets worse

    -symptoms clear up and then occur again within a few days

    -a rash or other allergic reaction occurs

  • ASK DOCTOR

    Ask a doctor before use if you have

    deep or puncture wounds

    animal bites

    serious burns

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  
    neomycin, bacitracin, polymyxin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN.41 g  in 100 g
    NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN.0035 g  in 100 g
    POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B.52 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-009-0128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

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