Label: VITACILINA FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 81929-003-01, 81929-003-02
  • Packager: Taisho Pharmaceutical California Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient (in each gram)

    Bacitracin Zinc 400 units

    Neomycin sulfate 3.5 mg

    Polymyxin B sulfate 5,000 units

    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

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds 
    • animal bites 
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week 
    • condition persists to gets worse
    • rash or other allergic reaction develops

    Keep out of reach of children.

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

  • 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 15 to 30°C (59 to 86°F )
    • DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING. Tamper Evident:
  • Inactive ingredient

    petrolatum

  • Package Labeling 28g

    Outer Package

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    Inner Package

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  • Package Labeling 14g

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    VITACILINA FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81929-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81929-003-011 in 1 CARTON07/01/2022
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81929-003-021 in 1 CARTON07/01/2022
    214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00407/01/2022
    Labeler - Taisho Pharmaceutical California Inc. (603827635)
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