Label: QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, 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 October 12, 2016

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  • 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)