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

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  • TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]
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NDC 63187-039-01, 63187-039-15
Set ID 45b1c4da-11ac-4e3a-8c77-0b0cdb78df24
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • ACTIVE INGREDIENTS

    (in each gram)

    Bacitracin zinc, USP 400 units

    Neomycin sulfate, USP 3.5 mg

    Polymyxin B sulfate, USP 5,000 units

  • PURPOSE

    First aid antibiotic

  • USES

    Helps prevent infection in

    •
    minor cuts
    •
    scrapes
    •
    burns
  • WARNINGS

    For external  use only

    Allergy alert:

    •
    do not use if allergic to any of the ingredients
  • DO NOT USE

    •
    in the eyes
    •
    over 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 unless directed by a doctor
  • STOP USE AND ASK A DOCTOR IF

    •
    condition persists or gets worse
    •
    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 affected area
    •
    apply a small 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

    •
    Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
    •
    Protect from freezing.
  • INACTIVE INGREDIENT

    White petrolatum

  • QUESTIONS?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 63187-039-01

    Triple Antibiotic Ointment

    FIRST AID ANTIBIOTIC

    (Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment)

    First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns

    Compare to the active ingredients in Neosporin®*

    NET WT 1 OZ (28 g)

    *This product is not affiliated with, manufactured by, or produced by the makers of Neosporin®.

     
    01791210G1 VC110203

    Distributed by:

    Actavis Pharma, Inc.

    Parsippany, NJ 07054 USA

    Made in India

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-039-15
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-039(NDC:0472-0179)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-039-1514 g in 1 TUBE; Type 0: Not a Combination Product05/01/2015
    2NDC:63187-039-0128 g in 1 TUBE; Type 0: Not a Combination Product04/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2003
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-039)
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