Bacitracin Zinc Ointment USP

Manufacturer: H.J. Harkins Company, Inc. | Nycomed US Inc.
Effective date: 2011-08-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:20

Label at a glance#

ProductBacitracin Zinc

Active ingredientBacitracin Zinc

Label structure3 sections

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

OTC - PURPOSE SECTION

Antibiotic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings For External use only

OTC - DO NOT USE SECTION

Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

When using this product do not use longer than 1 week unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if the condition persists or gets worse if a rash or other allergic reaction develops

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 right away.

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

Other information store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredient white petrolatum

OTC - QUESTIONS SECTION

E. FOUGERA and CO.
a division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

Repacked by:
H.J. Harkins Company Inc.
Nipomo, CA 93444

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-113-03	2020-01-31	C162847	48780-1	9d75b9d0-cdc6-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
52959-113-15	2020-01-31	C162847	48780-1	9d75b9d0-cdc6-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-113-03	Bacitracin Zinc	28.34 g in 1 TUBE	OINTMENT	28.34		1
52959-113-15	Bacitracin Zinc	14.17 g in 1 TUBE	OINTMENT	14.17		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-113	BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20110826_a6e5e9ad-cd0d-4d7a-bb74-5b9f913271eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-113-03	GM - Gram	52959-113	606a6f06-0530-46ed-8492-a4c66d9c5b4f	1	2013-02-13
52959-113-15	GM - Gram	52959-113	6b755845-fdee-4003-b8ec-bad6db2f04d8	1	2012-07-24
0168-0011-04	GM - Gram	0168-0011	4183200d-0ee7-44ec-a61d-ccb0d96daa26	1	2012-07-24
0168-0011-16	GM - Gram	0168-0011	aa72cf65-9ace-4b68-8623-723b2ad7296f	1	2012-07-24
0168-0011-31	GM - Gram	0168-0011	663eb974-383e-42dd-a023-a6f3912a99ed	1	2012-07-24
0168-0011-35	GM - Gram	0168-0011	b803f724-f27a-4037-8869-cb8b8f139d2e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	1
Bacitracin Zinc	ACTIVE MOIETY	89Y4M234ES	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

Bacitracin Zinc
petrolatum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52959-113	52959-113-03, 52959-113-15
0168-0011

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Bacitracin Zinc	89Y4M234ES	ACTIB
petrolatum	4T6H12BN9U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
petrolatum	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates

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
cad74dc9-a202-4e5d-b927-b2251079a170			a6e5e9ad-cd0d-4d7a-bb74-5b9f913271eb	2011-08-19	Warnings	Exact identifier spl id: cad74dc9-a202-4e5d-b927-b2251079a170 spl set id: a6e5e9ad-cd0d-4d7a-bb74-5b9f913271eb

Reported adverse events (FAERS/openFDA)#

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