TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]

TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-019-36, 52000-019-37
Set ID dbc66ae7-6c0a-4fc3-b7a7-78e4656a29c0
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active Ingredients

    Bacitracin Zinc 400U

    Neomycin 3.5 mg

    Polymyxin B Sulfate 5000U

  • 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 on

    • on deep puncture wounds, animal bites, or serious burns
  • STOP USE

    Stop use and consult a doctor if the condition persists or gets worse, or if 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 and dry thoroughly
    • 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)
    • Lot No. & Exp. Date: see crimp of tube
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cocoa butter, Petrolatum, Cotton seed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Triple Antibiotic First Aid Ointment

    NET WT 0.5 OZ (14 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC FIRST AID 
    bacitracin zinc, neomycin and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-019
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    COTTONSEED OIL (UNII: H3E878020N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-019-371 in 1 BOX
    1NDC:52000-019-3614 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/15/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-019)

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