Vitastem Ultra Ointment
FDA Label NDC 71262-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Viaderma Distribution, Inc for the product Vitastem Ultra (NDC 71262-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    • Stop use if product is misused

    • 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

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

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