Label: TRIPLE ANTIBIOTIC ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 2, 2010

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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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