Label: FAMILY WELLNESS- neomycin, bacitracin, polymyxin 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 July 31, 2013

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  • 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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