Label: BACITRACIN ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 12, 2024

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  • ACTIVE INGRIDIENT

    Active Ingredient (in each gram) Purpose

    Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

  • USES

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

  • WARNINGS

    For External Use Only

  • DO NOT USE

    Do not use In the eyes or over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a
    doctor.

  • ASK A DOCTOR

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

  • DO NOT USE

    Stop use and ask 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.

  • DIRECTION

    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.

  • OTHER INFORMATION

    Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature
    See crimp of tube or carton for Lot Number and Expiry Date Preserve in well-closed containers, preferably at controlled room temperature.

  • INACTIVE INGREDIENTS

    Mineral Oil, Paraffin, White Petrolatum

  • dosage and administration

    Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by
    a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting,
    ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for
    2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails

  • Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

    Active Ingredient (in each gram) Purpose
    Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

  • PRINCIPAL DISPLAY PANEL

    BACITRICIN

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84387-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84387-002-0128.4 g in 1 TUBE; Type 0: Not a Combination Product10/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00410/24/2024
    Labeler - ALLIED TRADE LINK LLC (029033682)
    Registrant - ALLIED TRADE LINK LLC (029033682)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOPALDAS VISRAM AND COMPANY LMITED858030888manufacture(84387-002)