Label: FAMILY WELLNESS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 69571-003-01, 69571-003-02
  • Packager: FRONT PHARMACEUTICAL PLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each gram)

    Bacitracin 400 units

    Neomycin 3.5 mg

    Polymyxin B 5,000 units

  • PURPOSE

    Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • INDICATIONS & USAGE

      first aid to help prevent infection in minor: Uses

    -uses     -scrapes   -burns

  • WARNINGS

    Warnings

    . For external use only

    Do not use

    Ask a doctor before use if you have

    Stop use and ask a doctor if

    • if you are allergic to any of the ingredients in this product
    • in contact with the eyes or mucous membranes
    • over large areas of the body
    • deep or puncture wounds
    • animal bites
    • serious burns
    • symptoms persist for mroe 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
  • KEEP OUT OF REACH OF CHILDREN

    . If swallowed, get medical help or Keep out of reach of children

    contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:

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

    • 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.
  • STORAGE AND HANDLING

      store at room temperature 68 - 77 F Other information

    (20-25 C).

  • QUESTIONS

      1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

  • INACTIVE INGREDIENT

      mineral oil, petrolatum Inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN0.41 g  in 100 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 100 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B0.52 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-003-021 in 1 BOX02/22/2017
    1NDC:69571-003-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00402/22/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-003)
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