TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate , polymyxin b sulfate ointment 
Trifecta Pharmaceuticals Usa Llc

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

DRUG FACTS

Active ingredient (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, 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 crimp 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
www.trifecta-pharma.com

Packaging

Triple Antibiotic

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate , polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-015-051 in 1 BOX03/18/2016
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-015-201 in 1 BOX03/18/2016
228.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/18/2016
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 1/2023
Document Id: f2766ee8-5652-b088-e053-2a95a90a6c0d
Set id: d04b397c-1608-4fd9-be28-ef7285d6a996
Version: 6
Effective Time: 20230117
 
Trifecta Pharmaceuticals Usa Llc