Label: BACITRACIN ZINC- first aid antibiotic ointment

  • NDC Code(s): 67777-008-10, 67777-008-20, 67777-008-30, 67777-008-50, view more
    67777-008-60
  • 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 September 18, 2020

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  • Active Ingredient

    Bacitracin Zinc (500 units in each gram)

  • Purpose

    First Aid Antibiotic

  • Uses

    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

    Stop use and ask a doctor if

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

    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
    • Avoid excessive heat and humidity
    • Tamper Evident. Do not use if inner seal is torn, cut or opened.
  • Inactive Ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • 1171 Label

    1171 BX MASTER

  • 1172 Label

    1172 Bacitracin Zinc

  • 1173 Label

    1173 Bacitracin Zinc Ointment

  • 1175 Label

    1175 Bacitracin Zinc

  • 1176 Label

    1176 Bacitracin Zinc

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-008-101728 in 1 CASE02/16/2018
    1144 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-008-2072 in 1 CASE02/16/2018
    21 in 1 BOX
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-008-3072 in 1 CASE02/16/2018
    31 in 1 BOX
    328.4 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:67777-008-5072 in 1 CASE02/16/2018
    41 in 1 BOX
    4113 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:67777-008-6012 in 1 CASE02/16/2018
    5425 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/16/2018
    Labeler - Dynarex Corporation (008124539)