DR TEALS TRIPLE ANTIBIOTIC (BACTRACIN, NEOMYCIN, POLYMYXIN B) OINTMENT [ADVANCED BEAUTY SYSTEMS, INC.]

DR TEALS TRIPLE ANTIBIOTIC (BACTRACIN, NEOMYCIN, POLYMYXIN B) OINTMENT [ADVANCED BEAUTY SYSTEMS, INC.]
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NDC 51345-106-01
Set ID d042977d-3333-4522-bce8-28e85f92ceb6
Category HUMAN OTC DRUG LABEL
Packager Advanced Beauty Systems, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active Ingredients (in each gram) Purpose

    Bacitracin 400 units First aid antibiotic

    Neomycin 3.5mg First aid antibiotic

    Polymyxin B 5,000 units First aid antibiotic

    Uses first aid to help prevent infection in minor -cuts -scrapes -burns

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

    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 develop

    Warnings For external use only

    Do not use -if you are allergic to any 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

    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

    Inactive Ingredient: White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    image of carton artimage of tube art


    Dr Teals

    Therapeutic Solutions

    First aid relief

    Triple Antibiotic Ointment

    Bacitracin Zinc

    Neomycin Sulfate

    Polymyxin B Sulfate

    Prevents infection in minor cuts, scrapes, and burns

    Net Wt 28 g 1oz

  • INGREDIENTS AND APPEARANCE
    DR TEALS  TRIPLE ANTIBIOTIC
    bactracin, neomycin, polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 28 g
    NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 28 g
    POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51345-106-0128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/06/2012
    Labeler - Advanced Beauty Systems, Inc. (129986613)
    Registrant - Advanced Beauty Systems, Inc. (129986613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Faria Limited dba Sheffield Pharmaceuticals151177797manufacture(51345-106)

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