VITASTEM ULTRA- bacitracin zinc ointment

Vitastem ULTRA by

Drug Labeling and Warnings

Vitastem ULTRA by is a Otc medication manufactured, distributed, or labeled by ViaDerma Distribution, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:71262-007-55

INGREDIENTS AND APPEARANCE

VITASTEM ULTRA 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71262-007
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71262-007-15	1 in 1 CARTON	06/01/2021
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71262-007-55	1 in 1 CARTON	06/01/2021
2		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	06/01/2021

Labeler - ViaDerma Distribution, Inc (081113521)