Label: FAMILY WELLNESS ANTISEPTIC AND PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment

  • NDC Code(s): 69571-007-01
  • Packager: FRONT PHARMACEUTICAL PLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each gram)

    Bacitricin zinc 500 units

    Neomycin  3.5 mg

    Polymyxin B  10,000 units

    Pramoxine hydrochorlide 10 mg

  • PURPOSE

    Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Pain reliever

  • INDICATIONS & USAGE

    Uses

    helps prevent infection in and reduces paid due to

    •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

  • STORAGE AND HANDLING

    Other information

    •store at room temperature 68° - 77° (20° - 25° C)

  • 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-box

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS ANTISEPTIC AND PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN0.51 g  in 100 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE0.0035 g  in 100 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B1 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-007-011 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(69571-007)
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