FACE VALUES TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE) OINTMENT [HARMON STORES INC.]

FACE VALUES TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE) OINTMENT [HARMON STORES INC.]
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NDC 63940-542-28
Set ID 3dbef234-dd37-4cef-b85c-8d6c49dfa879
Category HUMAN OTC DRUG LABEL
Packager HARMON STORES INC.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active Ingredients (each gram contains)                                                                   Purpose

    Bacitracin 400 units ...............................................................................................First Aid Antibiotic

    Neomycin Sulfate equivalent to 3.5mg of Neomycin Base..........................................First Aid Antibiotic

    Polymyxin-B Sulfate 5000 units ..............................................................................First Aid Antibiotic

  • PURPOSE

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other information

    • store at 15o to 25oC (59o to 77oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    liquid paraffin, white petrolatum, polyoxyl 40 stearate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water

  • DOSAGE & ADMINISTRATION

    Distributed by Harmon Stores, Inc.

    650 Liberty Avenue

    Union, NJ 07083 USA

    www.facevalues.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    FACE VALUES TRIPLE ANTIBIOTIC  
    bacitracin, neomycin sulfate, polymyxin-b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-542
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (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 B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-542-281 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/01/2012
    Labeler - HARMON STORES INC. (804085293)

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