Label: BACITRACIN ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • ACTIVE INGREDIENT

    Active ingredient               Purpose
    Bacitracin 500 Units                Antibiotic

  • Warnings:

    For external use only

    Dosage and Administration:

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

    Stop use and ask a doctor if

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

    Do not use:

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

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

  • Purpose

    First aid to help prevent infection in:
    Minor cuts
    scrapes
    burns

  • Indications and Usage

    Ask a doctor before use:

    •
    in case of deep or puncture wounds
    •
    animal bites
    •
    serious burns
  • Other information

    •
    store at controlled room temperature 15°-30° C (59°-86° F)
  • Inactive ingredients

    Light Mineral Oil, White Petrolatum

  • Principal Display Panel

    Relabeled By:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    Bacitracin Ointment:

    bacitracin-galentic-ointment-01.jpg

    63187-299-01
  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-299(NDC:67777-219)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-299-0128.35 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00412/01/2009
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-299) , RELABEL(63187-299)
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