Drug Facts

Manufacturer: TWIN MED, LLC
Effective date: 2026-08-03
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: daily-update
Hydrated at: 2026-08-05 06:00:10

Label at a glance#

ProductProcureTriple Antibiotic Triple Antibiotic

Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Label structure6 sections

Indications and uses

First aid to prevent infection in Minor cuts Scrapes Burns

Dosage and administration

Clean the affected area Apply small amount of this product(an amount equal to the surface area of the tip of the finger on the area 1 to 3 times daily May be covered with a sterile bandage

Label contents#

Full prescribing information#

Active Ingredients(in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc............400 units
Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)
Polymyxin B Sulfate ....5000 units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to prevent infection in

Minor cuts
Scrapes
Burns

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area
Apply small amount of this product(an amount equal to the surface area of the tip of the finger on the area 1 to 3 times daily
May be covered with a sterile bandage

Warnings

WARNINGS SECTION

For External Use Only.

Do not use

OTC - DO NOT USE SECTION

In the eyes
If you are allergic to any of the ingredients
Over large areas of the body
Longer than 1 week unless directed by a doctor
Ask a doctor before use in case of 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 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 Centre right away

Other information

OTHER SAFETY INFORMATION

Store at controlled room temperature 15 ^o- 30 ^oC(59 ^o--86 ^oF)
Avoid excessive heat and humidity
Tamper Evident
Do not use if packet is torn, cut or opened.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

White Soft Paraffin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelDrug Fact and PDP

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0816516015779	GTIN-13: 0816516015779 EAN-13: 0816516015779 GTIN-12: 816516015779 UPC-A: 816516015779 GTIN storage (14 digits): 00816516015779	Triple Antibiotic 1oz tube - Procure.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
55681-216-01	2021-09-28	C162847	48780-1	9d75b9cf-d823-f424-e053-dadaa90a57ce	Drug Facts
55681-216-01	2021-09-28	C162847	48780-1	9d75b9cf-d823-f424-e053-dadaa90a57ce	Drug Facts
55681-216-01	2020-01-31	C162847	48780-1	9d75b9cf-d823-f424-e053-dadaa90a57ce	Drug Facts
55681-216-01	2020-01-31	C162847	48780-1	9d75b9cf-d823-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

ProcureTriple Antibiotic Triple Antibiotic
BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B
BACITRACIN ZINC
BACITRACIN
NEOMYCIN SULFATE
NEOMYCIN
POLYMYXIN B SULFATE
POLYMYXIN B
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55681-216	55681-216-01, 55681-216-02

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
NEOMYCIN SULFATE	057Y626693	ACTIM
POLYMYXIN B SULFATE	19371312D4	ACTIM
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
9	2025-06-20	full-release	2026-06-01 01:03:37

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL	7275 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL	7275 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL	7275 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c2088c7a36db…`
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…`

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
ProcureTriple Antibiotic Triple Antibiotic	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B	TWIN MED, LLC	71592776-407b-489c-8cdb-8c0573d844f8	2026-08-03	Warnings	Exact identifier ndc (package): 55681-216-01 ndc (package): 55681-216-02 ndc (product): 55681-216 ndc11 (package): 55681021601 ndc11 (package): 55681021602 spl id: 5826cdd2-5b3d-7c2f-e063-6294a90a3fb1 spl set id: 71592776-407b-489c-8cdb-8c0573d844f8

Reported adverse events (FAERS/openFDA)#

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