Label: BUDPAK TRIPLE ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc, neomycin sulfate and polymyxin b sulfate 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 June 11, 2013

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  • 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, Cottonseed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Budpak Triple Antibiotic

    First Aid Antibiotic Ointment

    NET WT 0.5 OZ (14 g)

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPAK TRIPLE ANTIBIOTIC MAXIMUM STRENGTH 
    bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-024
    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:27293-024-011 in 1 BOX
    1NDC:27293-024-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/10/2013
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-024)
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