Label: SHOPKO TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 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 January 6, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)                                                                                 Purpose

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

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

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

    Pramoxine hydrochloride 10mg ...................................................................................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 allergic 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

    liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703

    www.ueccorp.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    SHOPKO TRIPLE ANTIBIOTIC PLUS 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-626
    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 SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 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
    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:55264-626-961 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/06/2011
    Labeler - UNITED EXCHANGE CORP. (840130579)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture
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