Neomycin Sulfate Ointment

Manufacturer
Aldermed Inc.
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:44:13

Label at a glance#

ProductNeomycin Sulfate
Active ingredientNEOMYCIN SULFATE
Label structure13 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Use(s)

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 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

OTC - ASK DOCTOR SECTION

■ if you have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ the condition persist or get worse

■ a rash or other 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 Center right away.(1-800-222-1222)

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

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

  • See sachet or carton for lot number and expiry date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-833-605-84-74 9am-5 pm EST M-F

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxboxlabellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87236-017-09Neomycin Sulfate0.9 g in 1 PACKETOINTMENT0.92
87236-017-09Neomycin Sulfate25 in 1 BOXOINTMENT252

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87236-01787236-017-09

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
NameUNIIKind
NEOMYCIN SULFATE057Y626693ACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin SulfateNEOMYCIN SULFATEAldermed Inc.4978bb06-8b7c-9a44-e063-6294a90ac4cf2026-02-12WarningsExact identifier
ndc (package): 87236-017-09
ndc (product): 87236-017
ndc11 (package): 87236001709
spl id: 4aa861be-67a7-d8e7-e063-6294a90ade6b
spl set id: 4978bb06-8b7c-9a44-e063-6294a90ac4cf

Reported adverse events (FAERS/openFDA)#

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