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]
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NDC 71205-006-28
Set ID 949c5b44-ee52-4913-8872-39181d319998
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc, USP 400 units
    Neomycin 3.5 mg
    Polymyxin B sulfate, USP 5,000 units

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help 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 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

    •
    Store at controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.
    •
    Before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredient

    white petrolatum

  • Questions?

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

  • Principal Display Panel

    MAJOR®

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    Protection Against Infection

    NDC 71205-006-28

    ORIGINAL STRENGTH
    TRIPLE ANTIBIOTIC OINTMENT
    Bacitracin Zinc–Neomycin Sulfate–Polymyxin B Sulfate
    FIRST AID ANTIBIOTIC

    Compare to the Active Ingredients in Neosporin®*  
    NET WT 1 OZ (28 g)

    71205-006-28
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-006(NDC:0904-0734)
    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:71205-006-281 in 1 CARTON04/02/2018
    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 finalpart333B06/01/2011
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-006)
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