Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate

Manufacturer: Henry Schein
Effective date: 2025-11-25
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:18:11

Label at a glance#

ProductBacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate

Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN ZINC

Label structure8 sections

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.

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (400 units)

Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin)

Polymyxin B Sulfate 5000 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Use(s)

INDICATIONS & USAGE SECTION

First aid to 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 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

• A rash or other allergic reaction develops

Keep our of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contract a Poison Control Center (1-800-222-1222) 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

OTHER SAFETY INFORMATION

• Store at room temperature 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if seal if torn, cut, or opened.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

White Petrolatum

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HS-570-3130 BX MASTER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	4
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	4
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0304040171509	GTIN-13: 0304040171509 EAN-13: 0304040171509 GTIN-12: 304040171509 UPC-A: 304040171509 GTIN storage (14 digits): 00304040171509	HS-570-3130 BX MASTER (R220801-1).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0404-0171-50	2024-01-31	C162847	48780-1	1030e365-0ab0-111a-e063-dadaa90a10e2	570-3130 Triple Antibiotic NDC 0404-0171-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-0171-50	Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate	72 in 1 CASE	OINTMENT	72		4
0404-0171-50	Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate	1 in 1 BOX	OINTMENT	1		4

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
POLYMYXIN B SULFATE
POLYMYXIN B
WHITE PETROLATUM
NEOMYCIN SULFATE
NEOMYCIN
BACITRACIN ZINC
BACITRACIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0404-0171	0404-0171-50

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
POLYMYXIN B SULFATE	19371312D4	ACTIM
WHITE PETROLATUM	B6E5W8RQJ4	IACT
NEOMYCIN SULFATE	057Y626693	ACTIB
BACITRACIN ZINC	89Y4M234ES	ACTIB

Source Document#

Source XML

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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
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…`

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, Polymyxin B Sulfate, and Neomycin Sulfate	BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE	Henry Schein	eadb847e-aefe-41cf-e053-2995a90af2cd	2025-11-25	Warnings	Exact identifier ndc (package): 0404-0171-50 ndc (product): 0404-0171 ndc11 (package): 00404017150 spl id: 446e5eab-25ec-f12c-e063-6394a90a9c12 spl set id: eadb847e-aefe-41cf-e053-2995a90af2cd

Reported adverse events (FAERS/openFDA)#

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