PREMIER VALUE TRIPLE ANTIBIOTIC PLUS (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [TAI GUK PHARM. CO., LTD.]

PREMIER VALUE TRIPLE ANTIBIOTIC PLUS (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [TAI GUK PHARM. CO., LTD.]
PDF | XML

NDC 68169-0129-5
Set ID fce6acbd-0387-4c84-9475-c67647bf3299
Category HUMAN OTC DRUG LABEL
Packager TAI GUK PHARM. CO., LTD.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredients (in each gram)                                                                           Purpose

    Bacitracin zinc 500 units ......................................................................................First aid antibiotic

    Neomycin 3.5 mg ................................................................................................First aid antibiotic

    Polymyxin B sulfate 10,000 units ..........................................................................First aid antibiotic

    Pramoxine hydrochloride 10 mg ............................................................................Pain reliever

  • PURPOSE

    Uses

    helps prevent infection and temporarily relieves pain due to minor cuts, scrapes, and burns.

  • WARNINGS

    Warnings

    For external use only

    Allergy alert: do not use if allergies to any of the ingredients

  • DO NOT USE

    Do not use

    • in or near the eyes
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING

    When using this product

    do not use longer than 1 week

  • STOP USE

    Stop use and ask a doctor if

    • condition lasts or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • rash or other allergic reaction occurs
  • 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    Adults and children 2 years and older:

    • clean affected area
    • apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage
    • Children under 2 years: ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Chain Drug Consortium, LLC.

    3301 N.W. Corporate Blvd. Suite 101

    Boca Raton, FL 33431

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE TRIPLE ANTIBIOTIC PLUS 
    bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-0129-51 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/04/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture

Related Drugs