TRIPLE ANTIBIOTIC OINTMENT [B8 SALES, INC.]

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TRIPLE ANTIBIOTIC OINTMENT [B8 SALES, INC.]
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NDC 50607-5600-1, 50607-5600-2
Set ID 93611650-ec45-4b83-872e-b1e227bdec11
Category HUMAN OTC DRUG LABEL
Packager B8 Sales, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333
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  • SPL UNCLASSIFIED SECTION

    Triple Antibiotic Ointment™

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

    25 Packets

    Each Packet Net.Wt.0.9gm

  • Drug Facts

  • Active ingredients (in each gram)

    Bacitradn Zinc (400 units Bacitracin)

    Neomycin Sulfate 5 mg

    (equivalent to 3.5 mg Neomycin base)

    Polymyxin-B Sulfate 5000 units

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    Do not use

    • in the eyes
    • internally
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor
  • Stop use and ask a doctor If

    • the condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep out reach of children. If swallowed, get

    medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years and over:

    • 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 dally
    • may be covered with a sterile bandage

    Children under 2 years:

    • consult a doctor
  • Other information

    • store at room temperature (do not freeze)
    • do not use any opened or torn packets
  • Inactive ingredients

    petrolatum

    Triple Antibiotic Ointment™

    Manufactured for:

    B8 SALES

    Cincinnati,0hio 4521S

    888-826-6208

    www.b8sales.com

    PIO Put it on®

  • Principal Display Panel

    Triple Antibiotic Ointment – Carton Label

    PIO Put it on®

    Triple Antibiotic Ointment™

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

    25 Packets

    Each Packet Net.Wt.0.9gm

    Triple Antibiotic Ointment – Carton Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    triple antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50607-5600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc400   in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate5000   in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50607-5600-125 in 1 BOX
    1.9 g in 1 POUCH
    2NDC:50607-5600-2144 in 1 BOX
    2.9 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/01/2010
    Labeler - B8 Sales, Inc. (833208635)
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