FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HYDROCHLORIDE) OINTMENT [UNITED EXCHANGE CORP.]

FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HYDROCHLORIDE) OINTMENT [UNITED EXCHANGE CORP.]
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NDC 65923-523-14
Set ID 1c44e5c4-fe86-4a97-882e-29e03838b624
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredients (in each gram)                                                   Purpose

    Bacitracin 500 units....................................................................... First aid antibiotic

    Neomycin sulfate 3.5 mg................................................................ First aid antibiotic

    Polymyxin B sulfate 10,000 units...................................................... First aid antibiotic

    Pramoxine hydrochloride 10mg........................................................ First aid antibiotic

  • PURPOSE

    Uses

    first aid to help prevent infection and for temporarily relief of pain or discomfort 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
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • the condition persists or gets worse
    • rash or allerfic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center immediately

  • INDICATIONS & USAGE

    Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a stearile bandage
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    ethanol, liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos CA, 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin neomycin sulfate polymyxin b sulfate pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-523
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-523-141 in 1 CARTON09/15/2016
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/24/2014
    Labeler - United Exchange Corp. (840130579)
    Registrant - United Exchange Corp. (840130579)

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