BACITRACIN ZINC OINTMENT [GERITREX LLC]

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BACITRACIN ZINC OINTMENT [GERITREX LLC]
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NDC 54162-017-09, 54162-017-15, 54162-017-28
Set ID ab757ae5-108d-418b-b37c-e46c3ff37fbc
Category HUMAN OTC DRUG LABEL
Packager GERITREX LLC
Generic Name
Product Class
Product Number
Application Number PART333B
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  • ACTIVE INGREDIENT

    Active Ingredient:                                                 Purpose:

    Bacitracin Zinc  500 units (each gram)....................First Aid Antibiotic

  • Uses:

    Helps prevent infection in: Minor cuts, scrapes, and/or burns

  • INDICATIONS & USAGE

  • Warnings:

    FOR EXTERNAL USE ONLY
    Allergy Alert: Do not use if allergic to any of the ingredients.
    Do not use in eyes or on large areas of the body.
    Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
    When using this product, do not use longer than 1 week, unless directed by a doctor.
    Stop use and ask a doctor if condition lasts or gets worse, rahs or other allergic reaction develops.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN
    In the event of accidental ingestion, contact a Poison Control Center right away.

  • Directions:

    Clean affected area. Apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily. May be covered with a sterile bandage.

  • Inactive Ingredients:

    Mineral Oil and White Petrolatum

  • STORAGE AND HANDLING

    Other Information:

    Store at controlled room temperature
    59°-86°F (15°-30°C).

  • PRINCIPAL DISPLAY PANEL

    09

    15

    28

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-017
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-017-1515 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    2NDC:54162-017-2828 g in 1 TUBE; Type 0: Not a Combination Product11/01/2017
    3NDC:54162-017-090.9 g in 1 POUCH; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/15/2014
    Labeler - GERITREX LLC (112796248)
    Registrant - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-017)
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