Label: TRIPLE ANTIBIOTIC CVS- bacitracin, neomycin, polymyxin 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 November 20, 2017

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  • ACTIVE INGREDIENT

    Bacitracin 400 units, Neomycin 3.5 mg, Polymyxin B 5000 units

  • INDICATIONS & USAGE

    Uses

    First aid to help prevent infection and for temporary relief of pain or discomfort in minor: cuts, scrapes, and burns.

  • WARNINGS

    Warnings

    For external use only. Do not use     in the eyes, over large areas of the body.  When using this product keep out of eyes.  Rinse eyes with water to remove.  Do not puncture or incinerate.  Contents under pressure. Ask a doctor before use if you have condition or symptoms get worse or last more than one week, symptoms clear up and occur again within a few days.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:  clean the affected area, shake well before each use, spray a small amount of the product on the area 1 to 3 times daily.  May be covered with a sterile bandage.  Children under 2 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, Hydrogenated Styrene/Butadiene Copolymer, Mineral Oil, Pentylene Glycol

  • PURPOSE

    Purpose

    First aid antibiotic.


  • 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.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC  CVS
    bacitracin, neomycin, polymyxin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B500 U  in 1 g
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-047-0256 g in 1 CAN; Type 0: Not a Combination Product02/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/14/2014
    Labeler - CVS (062312574)
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