FDA.reportPublic FDA data

Vitastem Ultra Topical Antibiotic Spray

Manufacturer
Native First Health, LLC
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:19:24

Label at a glance#

ProductVitastem Ultra Topical Antibiotic
Active ingredientBACITRACIN ZINC
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (500 units Bacitracin in 1g)

Purpose

OTC - PURPOSE SECTION

First Aid/Antibiotic

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or punture wounds
  • animal bites
  • serious trauma

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Keep refrigerated

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, cholecalciferol, dimethyl sulfoxide, propanediol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82973-00082973-000-55

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RIACT
CHOLECALCIFEROL1C6V77QF41IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
PROPANEDIOL5965N8W85TIACT
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b61354f-1665-8b57-e063-6394a90a2a570ae5c58d-8a84-4193-8831-c7c8fc45b03e2025-01-10WarningsExact identifier
spl set id: 0ae5c58d-8a84-4193-8831-c7c8fc45b03e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.