Bacitracin Zinc

Manufacturer: Dynarex Corporation
Effective date: 2025-06-16
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:03:14

Label at a glance#

ProductBacitracin Zinc

Active ingredientBACITRACIN ZINC

Label structure12 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes, and 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 at room temperature Avoid excessive heat and humidity Tamper Evident. Do not use if inner seal is torn, cut or opened.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (500 units in each gram)

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

In the eyes or apply over large areas of the body
If you are allergic to any of the ingredients
Longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature
Avoid excessive heat and humidity
Tamper Evident. Do not use if inner seal is torn, cut or opened.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

1172 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1172 BX MASTER1172 Bacitracin Zinc

1173 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1173 BX MASTER1173 Bacitracin Zinc

1175 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1175 BX MASTER1175 Bacitracin Zinc

1176 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1176 IN MASTER

1171 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1171 BX GVIN0101171 Bacitracin Zinc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1366116	bacitracin zinc 500 UNT/GM Topical Ointment	PSN	12
1366116	bacitracin zinc 0.5 UNT/MG Topical Ointment	SCD	12
1366116	bacitracin zinc 500 UNT per GM Topical Ointment	SY	12

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67777-008-10	Bacitracin Zinc	12 in 1 CASE	OINTMENT	12		12
67777-008-11	Bacitracin Zinc	144 in 1 BOX	OINTMENT	144		12
67777-008-11	Bacitracin Zinc	0.9 g in 1 PACKET	OINTMENT	0.9		12
67777-008-20	Bacitracin Zinc	72 in 1 CASE	OINTMENT	72		12
67777-008-21	Bacitracin Zinc	14.2 g in 1 TUBE	OINTMENT	14.2		12
67777-008-21	Bacitracin Zinc	1 in 1 BOX	OINTMENT	1		12
67777-008-30	Bacitracin Zinc	72 in 1 CASE	OINTMENT	72		12
67777-008-31	Bacitracin Zinc	28.4 g in 1 TUBE	OINTMENT	28.4		12
67777-008-31	Bacitracin Zinc	1 in 1 BOX	OINTMENT	1		12
67777-008-50	Bacitracin Zinc	72 in 1 CASE	OINTMENT	72		12
67777-008-51	Bacitracin Zinc	113 g in 1 TUBE	OINTMENT	113		12
67777-008-51	Bacitracin Zinc	1 in 1 BOX	OINTMENT	1		12
67777-008-60	Bacitracin Zinc	12 in 1 CASE	OINTMENT	12		12
67777-008-61	Bacitracin Zinc	425 g in 1 JAR	OINTMENT	425		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-008-10	EA - Each	67777-008	a0ebd4b4-6e19-4673-8336-e7131686c9a0	1	2023-07-06
67777-008-20	GM - Gram	67777-008	3646dc3b-b675-4692-9fc8-2f7265d71945	1	2025-08-11
67777-008-21	GM - Gram	67777-008	d7370a1a-0491-4c44-8e87-7fa37edec766	1	2025-08-11
67777-008-30	GM - Gram	67777-008	3eef27f2-71ce-48f9-ba7e-79751dbd20b5	1	2025-08-11
67777-008-31	GM - Gram	67777-008	155a75c8-03fd-4601-b559-a6d1e5e10a67	1	2025-08-11
67777-008-50	GM - Gram	67777-008	2b28ccca-a563-4229-893a-1dab240c50fd	1	2025-08-11
67777-008-51	GM - Gram	67777-008	f3dce390-fe60-4d34-80d5-d9f93ad22569	1	2025-08-11
67777-008-60	GM - Gram	67777-008	b43c4c61-88a2-464b-ac1d-7e9530a8a8ad	1	2023-02-06
67777-008-61	GM - Gram	67777-008	8759180c-b4b8-43ae-a6ae-f02b563741f5	1	2023-02-06

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Bacitracin Zinc
First Aid Antibiotic
BACITRACIN
MINERAL OIL
WHITE PETROLATUM
PARAFFIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67777-008	67777-008-11, 67777-008-10, 67777-008-21, 67777-008-20, 67777-008-31, 67777-008-30, 67777-008-51, 67777-008-50, 67777-008-61, 67777-008-60

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
MINERAL OIL	T5L8T28FGP	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
PARAFFIN	I9O0E3H2ZE	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N000004-004	PAREDRINE	HYDROXYAMPHETAMINE HYDROBROMIDE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982		`e64feba35796…`

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
Bacitracin Zinc	FIRST AID ANTIBIOTIC	Dynarex Corporation	82cf8dd0-eef6-5871-e053-2991aa0a38cf	2025-06-16	Warnings	Exact identifier ndc (package): 67777-008-20 ndc (package): 67777-008-11 ndc (package): 67777-008-21 ndc (package): 67777-008-60 ndc (package): 67777-008-50 ndc (package): 67777-008-10 ndc (package): 67777-008-30 ndc (package): 67777-008-51 ndc (package): 67777-008-31 ndc (package): 67777-008-61 ndc (product): 67777-008 ndc11 (package): 67777000851 ndc11 (package): 67777000860 ndc11 (package): 67777000821 ndc11 (package): 67777000861 ndc11 (package): 67777000850 ndc11 (package): 67777000810 ndc11 (package): 67777000831 ndc11 (package): 67777000820 ndc11 (package): 67777000830 ndc11 (package): 67777000811 spl id: 37b6c5f2-0e91-5ec0-e063-6394a90a6499 spl set id: 82cf8dd0-eef6-5871-e053-2991aa0a38cf