TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]
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NDC 71927-003-02
Set ID f9d698e2-a122-48bb-8298-38c55ef36874
Category HUMAN OTC DRUG LABEL
Packager Orazen Inc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)

    Bacitracin Zinc         400 units

    Neomycin Sulfate    5 mg

    (3.5 mg of Neomycin base)

    Polymyxin B Sulfate 5000 units

  • PURPOSE

    Purpose

    First aid antibiotic

  • INDICATIONS & USAGE

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • SPL UNCLASSIFIED SECTION

    Other Information

    • store at room temperature 20°C to 25°C (68°F to 77°C)
    • do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening
  • INACTIVE INGREDIENT

    Inactive Ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Ointment

    Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate

    First Aid Antibiotic Ointment

    NET WT 0.5 oz (14.2 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-003
    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) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COTTONSEED OIL (UNII: H3E878020N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-003-021 in 1 CARTON07/12/2018
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/12/2018
    Labeler - Orazen Inc (080916640)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(71927-003)

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