BACITRACIN ZINC- 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.

----------

Bacitracin ZINC OINTMENT USP

Drug Facts

Active ingredient

Bacitracin Zinc 500 units

Purpose

First Aid Antibiotic

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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 ● longer than 1 week unless directed by a healthcare professional

Ask a healthcare professional before use in care of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a healthcare professional if ● the condition persists or gets worse ● a rash or allergic reaction develops

Directions

● clean the affected area
● 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:

aloe vera gel, light mineral oil, white petrolatum

Other information

● store between15° to 25°C ( 59° to 77°F) ● Lot No & Expiration Date: See box and tube crimp.

100% GUARANTEED

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

bacitracin 500

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-008
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-008-201 in 1 BOX04/07/2016
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 finalpart333B04/07/2016
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 4/2016
Document Id: dd2f31bd-101d-4f40-bfbf-fe7d26004471
Set id: 0a970384-1155-400b-9c73-c3e4563788be
Version: 1
Effective Time: 20160407
 
Trifecta Pharmaceuticals Usa Llc