Label: FAMILY CARE TRIPLE ANTIBIOTIC- neomycin, bacitracin, polymyxin b ointment

  • Category: HUMAN OTC DRUG LABEL

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 May 3, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients                                                                            Purpose

    Bacitracin 400 units----------------------------------------------------------First aid antibiotic

    Neomycin 3.5 mg------------------------------------------------------------First aid antibiotic

    Polymyxin B Sulfate 5,000 units--------------------------------------------First aid antibiotic

  • PURPOSE

    Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops
  • 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

    Directions

    • clean the affected area
    • apply a small amount of this product (an amount of equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
  • STORAGE AND HANDLING

    Other information

    store at 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    methylparaben, mineral oil, petrolatum, polyoxyl 40 stearate, propylparaben

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    www.ueccorp.com

    Toll Free: 1 800 814 8028

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    546.1

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE TRIPLE ANTIBIOTIC 
    neomycin, bacitracin, polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-046-331 in 1 CARTON09/15/2016
    19.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/19/2014
    Labeler - United Exchange Corp. (840130579)
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