Antibiotic Ointment

Manufacturer: Acme United Corporation | Acme United Corpoation
Effective date: 2024-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 20:49:07

Label at a glance#

ProductFirst Aid Only Antibiotic Neomycin Sulfate

Active ingredientNEOMYCIN SULFATE

Label structure9 sections

Indications and uses

first aid to help prevent infection in minor cuts scrapes 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

Contacts and useful links#

PhoneLabel contact800-835-2263

Label contents#

Full prescribing information#

Active Ingredient (Each gram contains)

OTC - ACTIVE INGREDIENT SECTION

Neomycin sulfate (equivalent to 3.5 mg Neomycin base)

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in

minor cuts
scrapes
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

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 out of the reach of children

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

SPL UNCLASSIFIED SECTION

Store at room temperature 59° to 77°F (15°to 25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

800-835-2263

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0924-5607	FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE (ANTIBIOTIC OINTMENT) OINTMENT [ACME UNITED CORPORATION]	3	Legacy NDC	20241121_60a1dbf8-c3b8-105f-e053-2991aa0aa5c7.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

First Aid Only Antibiotic Neomycin Sulfate
Antibiotic Ointment
PETROLATUM
NEOMYCIN SULFATE
NEOMYCIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0924-5607	0924-5607-03, 0924-5607-02, 0924-5607-05, 0924-5607-01
59898-730

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	IACT
NEOMYCIN SULFATE	057Y626693	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Water-Jel Neomycin Antibiotic	FIRST AID OINTMENT	Water-Jel Technologies	abea91a2-4453-406d-a7ed-3ffc19ef521a	2025-12-31	Warnings	Exact identifier ndc (product): 59898-730
38029777-2e6b-9cda-e063-6394a90ad0fc			60a1dbf8-c3b8-105f-e053-2991aa0aa5c7	2025-06-20	Warnings	Exact identifier spl set id: 60a1dbf8-c3b8-105f-e053-2991aa0aa5c7

Reported adverse events (FAERS/openFDA)#

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