Label: DR TEALS TRIPLE ANTIBIOTIC- bactracin, neomycin, polymyxin b 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 August 10, 2012

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  • 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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