CAREALL TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [NEW WORLD IMPORTS, INC]

CAREALL TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [NEW WORLD IMPORTS, INC]
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NDC 51824-052-01, 51824-052-09
Set ID 9c2d417e-6fec-42f4-9f0c-2ec79de9342d
Category HUMAN OTC DRUG LABEL
Packager New World Imports, Inc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • Active Ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg

    Polymyxin B Sulfate 5,000 units

  • PURPOSE

    First aid antibiotic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center immediately

  • INDICATIONS & USAGE

    First aid to help prevent infection in minor cuts, scrapes and burns

  • WARNINGS

    For external use only

    Do not use

    In the eyes

    If you are allergic to any of the ingredients

    Over large areas of the body

    Ask a doctor before use if you have

    Animal bites

    Serious Burns

    Deep or puncture wounds

    Stop use and ask a doctor if

    You need to use longer than 1 week

    condition persists or gets worse

    rash or other allergic reaction develops

  • DOSAGE & ADMINISTRATION

    Clean the affected area

    Apply a small amount of this product (an amount equal to the surface of th tip of a finger) on the area 1 to 3 times daily

    May be covered with a sterile bandage

  • INACTIVE INGREDIENT

    White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Triple Label

  • INGREDIENTS AND APPEARANCE
    CAREALL TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-052-0128 g in 1 TUBE; Type 0: Not a Combination Product03/15/2016
    2NDC:51824-052-09.9 g in 1 PACKET; Type 0: Not a Combination Product03/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/15/2016
    Labeler - New World Imports, Inc (075372276)