Bacitracin ZINC OINTMENT USP

Manufacturer: Trifecta Pharmaceuticals Usa Llc
Effective date: 2016-04-07
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:45:41

Label at a glance#

ProductBacitracin Zinc

Active ingredientBACITRACIN ZINC

Label structure10 sections

Indications and uses

● first aid to help prevent infection in ● minor cuts ● scrapes ● burns

Dosage and administration

● 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

Storage and handling

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

Contacts and useful links#

Websitewww.trifecta-pharma.com

www.trifecta-pharma.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

● first aid to help prevent infection in ● minor cuts ● scrapes ● burns

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

● 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:

INACTIVE INGREDIENT SECTION

aloe vera gel, light mineral oil, white petrolatum

Other information

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bacitracin 500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1366116	bacitracin zinc 500 UNT/GM Topical Ointment	PSN	1
1366116	bacitracin zinc 0.5 UNT/MG Topical Ointment	SCD	1
1366116	bacitracin zinc 500 UNT per GM Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BACITRACIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69396-008-20	2020-01-31	C162847	48780-1	9d75b9d1-26cd-f424-e053-dadaa90a57ce	Bacitracin ZINC OINTMENT USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69396-008-20	Bacitracin Zinc	1 in 1 BOX	OINTMENT	1		1
69396-008-20	Bacitracin Zinc	28 g in 1 TUBE	OINTMENT	28		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-008	BACITRACIN ZINC OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]	1	Legacy NDC, 2 package rows	20160413_0a970384-1155-400b-9c73-c3e4563788be.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-008-20	GM - Gram	69396-008	fc62863c-dbdf-4e10-8c4d-02f441c5ba1f	1	2019-04-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Bacitracin Zinc
BACITRACIN
ALOE VERA LEAF
LIGHT MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69396-008	69396-008-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BACITRACIN ZINC	89Y4M234ES	ACTIM
ALOE VERA LEAF	ZY81Z83H0X	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dd2f31bd-101d-4f40-bfbf-fe7d26004471			0a970384-1155-400b-9c73-c3e4563788be	2016-04-07	Warnings	Exact identifier spl id: dd2f31bd-101d-4f40-bfbf-fe7d26004471 spl set id: 0a970384-1155-400b-9c73-c3e4563788be

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.