TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [PROFICIENT RX LP]

TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [PROFICIENT RX LP]
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NDC 63187-649-15, 63187-649-30
Set ID 3e5c0f26-0b55-4868-b4f7-9c52e802fb44
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • Drug Facts

  • Active ingredients (in each gram)

     
    Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
     
    Polymyxin B Sulfate (equal to 5,000 polymyxin B units)
     
    Bacitracin Zinc (equal to 400 bacitracin units)
  • Purpose

    Antibiotic
    Antibiotic
    Antibiotic

    Uses

    first aid to help prevent infection in

    minor cuts
    scrapes
    burns
  • Warnings

  • For external use only

    Do not use

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

    Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

    When using this product do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    the condition persists or gets worse
    if a rash or other allergic reaction develops
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    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 sterile bandage

    Other information

    do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
    store at room temperature
    see crimp of tube for Lot No. and Exp. date

    Inactive ingredient white petrolatum

    Questions or comments? call toll free 1-800-645-9833

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

    Fougera®

    NDC 63187-649-15

    Triple Antibiotic Ointment
    (Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

    63187-649-15
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    neomycin and polymyxin b sulfates and bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-649(NDC:0168-0012)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-649-151 in 1 CARTON02/01/2016
    114.17 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63187-649-301 in 1 CARTON02/01/2016
    228.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/06/2010
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-649)

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