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.

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Urgent 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.

Ask Doctor Before Use

Ask Doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Do Not Use

Stop Use and ask a doctor

Stop Use and ask a doctor if

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


● store at 20° to 25°C ( 68° to 77°F)

Questions? Call 1-760-642-2638

Manufactured For

Manufactured for

Urgent First Aid®

2603 Industry Street

Oceanside, CA 92054

www.urgentfirstaid.com

CDER URG600Triple antibiotic ointment 6939612505

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-125
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)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-125-0525 in 1 BOX07/23/2023
10.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/18/2023
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 7/2023
Document Id: 00c51ee1-d7e8-17f1-e063-6394a90ac336
Set id: 00c52a31-9bfa-a8bf-e063-6294a90ac4d7
Version: 1
Effective Time: 20230718
 
TRIFECTA PHARMACEUTICALS USA LLC