First Aid Kit, Orazen Inc

Manufacturer: Orazen Inc
Effective date: 2026-06-03
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: daily-update
Hydrated at: 2026-06-06 05:10:12

Label at a glance#

ProductFirst Aid Kit, Orazen Inc

Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE

Label structure9 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-888-672-9630

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (3.5 mg of Neomycin)

Polymyxin-B Sulfate 5000 units

Purpose

OTC - PURPOSE SECTION

Purpose

First Aid antibiotic

First Aid Antibiotic

Use

INDICATIONS & USAGE SECTION

Use

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

Warnings

WARNINGS SECTION

Warnings

For external use only.

Do not use

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
longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have deep puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

Keep out of reach of children

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.

Directions

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

Other information

SPL UNCLASSIFIED SECTION

Other information

Store at 15°C to 25°C (59°F to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

petrolatum

Questions?

OTC - QUESTIONS SECTION

Questions?call toll-free 1-888-672-9630(M-F 8AM-4:30PM CST)

First Aid Kit, Orazen Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Orazen Inc. logo]

First Aid Kit

5 Adhesive Bandages

2 Antibiotic Ointments

Bacitracin Zinc, Neomycin Sulfate 5 mg,
Polymyxin-B Sulfate

[white cross reverse out of red square background]

NET WT 1/57 OZ (0.5 g)

02045 Orazen First Aid Kit

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0850025020459	GTIN-13: 0850025020459 EAN-13: 0850025020459 GTIN-12: 850025020459 UPC-A: 850025020459 GTIN storage (14 digits): 00850025020459	Orazen 02045_FirstAidKit.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

First Aid Kit, Orazen Inc
5 Adhesive Bandages, 2 Antibiotic Ointments
First Aid Kit
5 Adhesive Bandages plus 2 Antibiotic Ointments
Ora Zen Triple Antibiotic
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
PETROLATUM
BACITRACIN ZINC
BACITRACIN
POLYMYXIN B SULFATE
POLYMYXIN B
NEOMYCIN SULFATE
NEOMYCIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71927-036	71927-036-01
71927-034	71927-034-01

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
PETROLATUM	4T6H12BN9U	IACT
BACITRACIN ZINC	89Y4M234ES	ACTIM
POLYMYXIN B SULFATE	19371312D4	ACTIM
NEOMYCIN SULFATE	057Y626693	ACTIM

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Kit, Orazen Inc	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Orazen Inc	525bcb89-af5b-8652-e063-6294a90a41a6	2026-06-03	Warnings	Exact identifier ndc (package): 71927-036-01 ndc (package): 71927-034-01 ndc (product): 71927-036 ndc11 (package): 71927003401 ndc11 (package): 71927003601 spl id: 535c2543-84de-f5c1-e063-6394a90adb1e spl set id: 525bcb89-af5b-8652-e063-6294a90a41a6
First Aid Kit, Lil Drug Store	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Lil' Drug Store Products, Inc.	503c6c0e-3e1a-71ed-e063-6394a90abfa2	2026-04-24	Warnings	Exact identifier ndc (package): 71927-034-01 ndc11 (package): 71927003401
Ora Zen Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	abbf8c34-87cb-4366-9840-7264a5114b54	2026-03-11	Warnings	Exact identifier ndc (package): 71927-034-01 ndc (product): 71927-034 ndc11 (package): 71927003401

Reported adverse events (FAERS/openFDA)#

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