TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [FRED'S, INC.]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [FRED'S, INC.]
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NDC 55315-180-56
Set ID 41ee7a50-d36b-4214-b6f8-44f47ab44a84
Category HUMAN OTC DRUG LABEL
Packager Fred's, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc USP 400 unitsFirst aid antibiotic
    Neomycin sulfate USP 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate USP 5,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Do not use

    • if you are allergic to any of the ingredients
    • 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

    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. 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

    • To open: unscrew cap, pull tab to remove foil seal
    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD,
    MEMPHIS, TN 38118

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    fred's
    Pharmacy

    NDC 55315-180-56

    Compare to the
    Active Ingredients in
    Neosporin®*

    TRIPLE ANTIBIOTIC
    OINTMENT

    ORIGINAL STRENGTH

    Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B Sulfate USP
    FIRST AID ANTIBIOTIC OINTMENT

    Helps Prevent Infection in Minor Cuts, Scrapes, and Burns.
    NET WT 1 oz (28.4g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-180
    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) Neomycin Sulfate3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    cocoa butter (UNII: 512OYT1CRR)  
    cottonseed oil (UNII: H3E878020N)  
    olive oil (UNII: 6UYK2W1W1E)  
    sodium pyruvate (UNII: POD38AIF08)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-180-561 in 1 CARTON11/15/2018
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/15/2018
    Labeler - Fred's, Inc. (005866116)

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