Label: VITASTEM ULTRA- bacitracin zinc ointment

  • NDC Code(s): 71262-007-15, 71262-007-55
  • Packager: ViaDerma Distribution, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Drug Facts

  • Active Ingredient

    Bacitracin Zinc (500 units Bacitracin in 1g)

    Purpose

    First Aid/Antibiotic

  • Uses

    First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

  • Warnings

    For external use only. May be harmful if swallowed.

    Allergy Alert

    Do not use if allergic to any ingredients in VitaStem™ ULTRA.

    Do not use

    • in eyes
    • over large areas of the body
    • longer than 1 week unless directed by doctor

    Ask a doctor before use if you have

    • deep or punture wounds 
    • animal bites
    • serious trauma

    Stop use and ask a doctor if 

    condition persists or gets worse.

    Keep out of reach of children.

    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
    • this product is an OTC antibiotic for human use
    • contains no alcohol, no animal ingredients
    • blended for typical skin color
    • no claims regarding stem cell healing are implied for this product

    Stop use if product is misused

  • Other Information

    • store in a cool dry place
  • Inactive Ingredients

    acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

  • Package Labeling:71262-007-15

    Outer Package2Inner Package2

  • Package Labeling:71262-007-55

    Outer Package3Inner Package3

  • INGREDIENTS AND APPEARANCE
    VITASTEM ULTRA 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71262-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 U  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HISTIDINE (UNII: 4QD397987E)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71262-007-151 in 1 CARTON06/01/2021
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71262-007-551 in 1 CARTON06/01/2021
    255 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00406/01/2021
    Labeler - ViaDerma Distribution, Inc (081113521)
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