Label: FAMILY WELLNESS- bacitracin zinc ointment

  • NDC Code(s): 69571-008-01
  • 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 zinc, USP 500 units

  • PURPOSE

    Purpose

    First aid antibiotic

  • INDICATIONS & USAGE

    Uses

    first aid to help prevent infection in

    •minor cuts  •scrapes  •burns

  • WARNINGS

    Warnings For external use only

    Allergy alert

    •do not use if allergic to any of the ingredients

    Do not use

    •in or near eyes

    •on large areas of the body

    Ask a doctor before use if you have

    •deep or puncture wounds

    •animal bites •serious burns

    When using this product

    •do not use longer than 1 week

    Stop use and ask a doctor if

    •condtions last or gets worse

    •symptoms last for more than 7 days or clear up and

    come back within a few days

    •if rash or other allergic reaction occurs

  • KEEP OUT OF REACH OF CHILDREN

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

    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    •adults and children 2 years of age and older:

    •clean affected area

    •apply a small amount (equal to surface area of tip of

    finger) on area 1 to 3 times dailt

    •may be covered by a sterile bandage

    •children under 2 years of age:

    •ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information

    •Store at room temperature 54° - 77° (15° - 25° C)

    •Before using any medication, read all label direcitons.

    Keep carton. It contains important information

  • INACTIVE INGREDIENT

    mineral oil, white petrolatum Inactive ingredients

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN0.51 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-008-011 in 1 CARTON06/13/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00406/13/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-008)
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