Vitastem Ultra

Vitastem Ultra
SPL v4
SPL
SPL Set ID fd96cc09-8522-44a5-b034-0d30e532410d
Route
TOPICAL
Published
Effective Date 2025-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 U)
Inactive Ingredients
Acetic Acid Ascorbic Acid Chlorhexidine Gluconate Cholecalciferol Dimethyl Sulfoxide Dipropylene Glycol Gluconolactone Glycerin Histidine Hydroxyethyl Cellulose, Unspecified Magnesium Stearate Sodium Hydroxide Sorbic Acid Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01

Description

Bacitracin Zinc (500 units Bacitracin in 1g)

Purpose

First Aid/Antibiotic


Medication Information

Purpose

First Aid/Antibiotic

Description

Bacitracin Zinc (500 units Bacitracin in 1g)

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.

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

Do Not Use
  • in eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor
Drug Facts

Active Ingredient

Bacitracin Zinc (500 units Bacitracin in 1g)

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

Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 

condition persists or gets worse.

Ask A Doctor Before Use If You Have
  • deep or punture wounds 
  • animal bites
  • serious trauma

Structured Label Content

Uses

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

Purpose

First Aid/Antibiotic

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert

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

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

Do Not Use (Do not use)
  • in eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor
Drug Facts

Active Ingredient

Bacitracin Zinc (500 units Bacitracin in 1g)

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:71262-007-15)

Package Labeling:71262 007 55 (Package Labeling:71262-007-55)

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

condition persists or gets worse.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or punture wounds 
  • animal bites
  • serious trauma

Advanced Ingredient Data


Raw Label Data

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