Label at a glance#

ProductBacitracin Zinc

Active ingredientBACITRACIN ZINC

Label structure14 sections

Contacts and useful links#

PhoneLabel contact1-800-645-9833

Label contents#

Full prescribing information#

Active Ingredient (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

Do not use

in the eyes
over large areas of the body
if you are allergic to any of the ingredients

Ask 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

Stop use and ask a doctor if

the condition persists or gets worse
if a rash or other allergic reaction develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
store at room temperature
see crimp of tube for Lot Number and Exp. Date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

white petrolatum

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0011-04

Fougera^®

NET WT 113.4 g (4 Oz)

FOR HOSPITAL USE ONLY

Bacitracin Zinc Ointment USP

First Aid Antibiotic

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera ^®

Bacitracin Zinc
Ointment USP

First Aid Antibiotic

NDC 0168-0011-04

FOR HOSPITAL USE ONLY

NET WT 113.4 g (4 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera^®

First Aid Antibiotic

Bacitracin Zinc
Ointment USP

Uses: First aid to help prevent infection

in . minor cuts . scrapes . burns

NET WT. 0.9 g (1/32 Oz)

NDC 0168-0111-09

PACKAGE LABEL &#8211; PRINCIPAL DISPLAY PANEL &#8211; 1/32 Oz CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0111-09

Fougera ^®

Bacitracin Zinc

Ointment USP

First Aid Antibiotic

This product available in tubes at pharmacy.

1 GROSS

NET WT. 0.9 g (1/32 Oz) FOILPACS^®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 lb jar CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera^®

NDC 0168-0011-16

NET WT 453.6 g (1 lb)

Bacitracin Zinc Ointment USP

First Aid Antibiotic FOR HOSPITAL USE ONLY

PACKAGE LABEL &#8211; PRINCIPAL DISPLAY PANEL &#8211; 1 lb jar CONTAINER

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1366116	Bacitracin (Topical)	bacitracin zinc 0.5 UNT/MG Topical Ointment	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0168-0011-04	2021-12-10	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-16	2021-12-10	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-31	2021-12-10	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-35	2021-12-10	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0111-09	2021-12-10	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-04	2020-01-31	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-16	2020-01-31	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-31	2020-01-31	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0011-35	2020-01-31	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP
0168-0111-09	2020-01-31	C162847	48780-1	9d75b9d0-b69e-f424-e053-dadaa90a57ce	Bacitracin Zinc Ointment USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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
0168-0111-09	EA - Each	0168-0111	879f2350-c3da-4ab7-9bbf-d53da491a81e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	2
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	2

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Bacitracin Zinc
BACITRACIN
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0168-0011	0168-0011-35, 0168-0011-31, 0168-0011-04, 0168-0011-16
0168-0111	0168-0111-09

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
PETROLATUM	4T6H12BN9U	IACT
BACITRACIN ZINC	89Y4M234ES	ACTIM
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML · Source PDF

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	SUPPOSITORY / VAGINAL	27 mg		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
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %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	OINTMENT / VAGINAL		4084 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	OINTMENT / TOPICAL		7275 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	OINTMENT / OPHTHALMIC	88.4 %w/w		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	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		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	OINTMENT / AURICULAR (OTIC)	NA		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	LIQUID / RESPIRATORY (INHALATION)	NA		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	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

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
b558e3e0-70d8-440b-8833-8719b77f4325			41810930-aa84-4ab4-9df6-0afb1706a25b	2021-09-22	Warnings	Exact identifier spl set id: 41810930-aa84-4ab4-9df6-0afb1706a25b

Reported adverse events (FAERS/openFDA)#

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

Bacitracin Zinc Ointment USP

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active Ingredient (in each gram):

Purpose:

INDICATIONS & USAGE SECTION

WARNINGS SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

Inactive Ingredients

SPL UNCLASSIFIED SECTION

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 lb jar CONTAINER

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#