Label: VITASTEM ULTRA TOPICAL ANTIBIOTIC- bacitracin zinc ointment

  • NDC Code(s): 82973-001-15
  • Packager: Native First Health, LLC
  • 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

  • Indications

    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

    • Keep refrigerated
  • Inactive Ingredients

    ascorbic acid, cholecalciferol, dimethyl sulfoxide, propanediol

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    VITASTEM ULTRA TOPICAL ANTIBIOTIC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82973-001
    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
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82973-001-151 in 1 CARTON09/01/2022
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00409/01/2022
    Labeler - Native First Health, LLC (118782998)
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