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Triple Antibiotic by TRIFECTA PHARMACEUTICALS USA LLC

Medically reviewed on May 10, 2018

Dosage form: ointment
Ingredients: BACITRACIN ZINC 400[USP'U] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 5000[USP'U] in 1g
Labeler: TRIFECTA PHARMACEUTICALS USA LLC
NDC Code: 69396-002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Triple Antibiotic Ointment

Active ingredients (each gram contains)

Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg 
Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings    For external use only.

Do not use ● in the eyes                             ● over large areas of the body

                   ● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds                     ● animal bites                        ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops 

Directions

 ● clean the affected area and dry thoroughly.

 ● 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.

Inactive ingredient light Mineral Oil, White Petrolatum

Other information

● To open: unscrew cap, pull tab to remove foil seal
● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube for lot number and expiration date.

Questions?  Call 1-888-296-9067

Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067

Packaging

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:69396-002-201 TUBE in 1 BOX
128.4 g in 1 TUBE
2NDC:69396-002-051 TUBE in 1 BOX
215 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/10/2015
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

 
TRIFECTA PHARMACEUTICALS USA LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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