VITASTEM ULTRA TOPICAL ANTIBIOTIC- bacitracin zinc spray

Vitastem Ultra Topical Antibiotic by

Drug Labeling and Warnings

Vitastem Ultra Topical Antibiotic by is a Otc medication manufactured, distributed, or labeled by Native First Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

VITASTEM ULTRA TOPICAL ANTIBIOTIC 
bacitracin zinc spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82973-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 U  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82973-000-55	1 in 1 CARTON	09/01/2022
1		55 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	09/01/2022

Labeler - Native First Health, LLC (118782998)