QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-910-01
Set ID 624d8fb4-c1f2-4e99-a3d2-0878092e59d6
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc
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.............................................. First aid analgesic

  • PURPOSE

    Uses

    Helps prevent infection and temporarily relieves pains 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 Poision Control Center right away.

  • INDICATIONS & USAGE

    Directions

    Adults and children 2 years of age and older:

    • clean the affected area
    • apply a small amount equal to surface area of a finger tip, on area 1 to 3 times daily
    • may be covered with a sterile bandage

    Children under 2 years of age: ask a doctor

  • STORAGE AND HANDLING

    Other information

    • Store at 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or crimp or tube
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    C.D.M.A., INC.

    43157 W. NINE MILE

    NOVI, MI 48376-0995 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-910
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-910-011 in 1 CARTON10/12/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/25/2014
    Labeler - Chain Drug Marketing Association Inc (011920774)

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