TRIASTEM TOPICAL ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Triastem Topical Antibiotic by

Drug Labeling and Warnings

Triastem Topical Antibiotic 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 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

Package Labeling:

INGREDIENTS AND APPEARANCE

TRIASTEM TOPICAL ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71262-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 mg  in 1 mL
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg  in 1 mL
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 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)
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: 71262-005-15	1 in 1 BOX	11/01/2019
1		15 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 final	part333B	11/01/2019

Labeler - ViaDerma Distribution, Inc. (081113521)