QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-945-94
Set ID dced282a-97f6-44a3-b3ab-bc19912844bd
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • PURPOSE

    Uses

    help prevent infection and temporarily relieves pain due to

    • minor cuts
    • scrapes
    • 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
    • longer than 1 week
  • 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

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and comes back within a few days
    • a 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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    white petrolatum, Polysorbate 80, Stearic acid polyoxil 40, Methylparaben, Propylparaben, Purified Water

  • DOSAGE & ADMINISTRATION

    Distributed By Quality Choice

    NOVI, MI 48376-0995

    MADE IN KOREA

    QC 94594

    www.chaindrug.com

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)                                                                      Purpose

    Bacitracin Zinc 500 units .................................................................................First aid antibiotic

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

    Polymyxin-B Sulfate 10,000 units.....................................................................First aid antibiotic

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

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER 
    bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-945
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-945-941 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/09/2012
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

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