Label: 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 January 17, 2018

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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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