TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment 
TRIFECTA PHARMACEUTICALS USA LLC

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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

image description

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-002
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:69396-002-201 in 1 BOX03/13/2017
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-002-051 in 1 BOX08/23/2016
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:69396-002-09144 in 1 BOX03/09/2022
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:69396-002-2525 in 1 BOX03/14/2023
40.9 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:69396-002-221 in 1 BOX02/01/2022
557 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:69396-002-232 in 1 BOX02/29/2024
628.4 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:69396-002-444 in 1 BOX02/29/2024
728.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00403/10/2015
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 2/2024
Document Id: 128c636a-b986-46ec-e063-6394a90a9e2d
Set id: 23a35ba8-ebc6-4252-bb88-ec237425056c
Version: 17
Effective Time: 20240229
 
TRIFECTA PHARMACEUTICALS USA LLC