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  5. Label Information: Triastem Topical Antibiotic

FDA Label for Triastem Topical Antibiotic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. INDICATIONS
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABELING:

Triastem Topical Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Viaderma Distribution, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Bacitracin Zinc 400mg in 1 g  
Neomycin Sulfate 5 mg in 1 g 
Polymyxin B Sulfate 5000 units in 1 g


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 TriaStem™.


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 puncture 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
    • may stain cloth
    • no claims regarding stem cell healing are implied for this product

Other Information



  • store in cool dark 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


* Please review the disclaimer below.