DOUBLEANTIBIOTICOINTMENT- bacitracin zinc, 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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Double Antibiotic Ointment

Active Ingredient

Bacitracin 500 Units

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B

Purpose

First Aid Double Antibiotic Ointment

Uses

First aid to help prevent infection in minor

Warnings

For External use only.

Do not use

Ask a doctor before use if you have:

Stop use and ask doctor if:

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Other Information

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

White Petrolatum

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

www.trifecta-pharma.com

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Consumer Products company, owner of the registered trademark Polysporin®

globe doble_antibiotic@2x-80.

DOUBLEANTIBIOTICOINTMENT 
bacitracin zinc, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-029-301 in 1 BOX05/04/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/04/2017
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2023
Document Id: f276c674-f98a-d6a5-e053-2a95a90a8e75
Set id: 4eb5202e-8e5b-6d31-e054-00144ff88e88
Version: 4
Effective Time: 20230117
 
Trifecta Pharmaceuticals USA LLC