Label: BACITRACIN ointment

  • NDC Code(s): 67777-116-10, 67777-116-11, 67777-116-20, 67777-116-21, view more
    67777-116-30, 67777-116-31
  • Packager: Dynarex Corporation
  • 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 November 22, 2022

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  • Active Ingredient

    Bacitracin (500 units in each gram)

  • Purpose

    First Aid Antibiotic

  • Use

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

  • Warnings

    For External Use Only

    Do not use

    • In the eyes or apply 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 before use if you have

    deep or puncture wounds, animal bites, or serious burns

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

  • 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.

  • Other information

    Store at room temperature

  • Inactive ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Label

    1161 BX MASTER1161 Bacitracin Ointment

  • Label

    1162 BX MASTER1162 Bacitracin Ointment

  • Label

    1163 BX MASTER1163 Bacitracin Ointment

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-116-2072 in 1 CASE09/12/2016
    1NDC:67777-116-2114000 mg in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67777-116-101728 in 1 CASE09/12/2016
    2NDC:67777-116-11144 in 1 BOX
    2900 mg in 1 PACKET; Type 0: Not a Combination Product
    3NDC:67777-116-3072 in 1 CASE09/12/2016
    3NDC:67777-116-311 in 1 BOX
    328400 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/12/2016
    Labeler - Dynarex Corporation (008124539)
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