Label: BUDPAK BACITRACIN- bacitracin zinc 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 March 31, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient (each gram contains):

    Bacitracin Zinc 500 units

  • PURPOSE

    Purpose:

    First aid antibiotic

  • INDICATIONS & USAGE

    Uses:

    First aid to help prevent infection in minor cuts, scrapes, and 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, over large areas of the body, longer than 1 week unless directed by a doctor.

  • ASK DOCTOR

    Ask a doctor before use:

    In case of deep or puncture wounds, animal bites or serious burns

  • STOP USE

    Stop use and ask a doctor if:

    Condition persists or gets worse. 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 immediately.

  • 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 15ºC to 25ºC (59ºF to 77ºF). Lot No. & Exp. Date: See  box or crimp of tube.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin .

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Budpak Bacitracin Ointment

    First Aid Antibiotic with Zinc

    NET WT .5 OZ (14 g)

    carton

  • INGREDIENTS AND APPEARANCE
    BUDPAK BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-035-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/30/2015
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-035)
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