BACITRACIN- bacitracin zinc 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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Bacitracin Zinc Ointment USP

Active Ingredient

Bacitracin Zinc 500 Units per gram

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in

Warnings

For External Use Only.

Do not use; in eyes, over large areas of the body, if you are allergic to any of the ingredients, longer than 1 week unless directed by a doctor.

.

Stop Use and Ask Doctor if

Directions

Inactive Ingredients

Aloe vera gel, light mineral oil, white petrolatum

Other Information

Store between 15º to 25ºC (59º to 77ºF)

Lot No and Expiration Dates - please see box and tube crimp

100% GUARANTEED

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Keep out of reach of children

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

Ask

4028 GLOBE BACITRACIN ZINC OINTMENT 1OZ REV04 060523 CDER

BACITRACIN 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-027-011 in 1 BOX03/15/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/15/2017
Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 9/2023
Document Id: 065df2c4-5b2b-1209-e063-6394a90ad421
Set id: 4a9fe0fa-5549-4e06-e054-00144ff8d46c
Version: 7
Effective Time: 20230927
 
Trifecta Pharmaceuticals USA, LLC.