FDA.reportPublic FDA data

Roosin Neomycin Antibiotic

Manufacturer
ROOSIN MEDICAL CO., LTD
Effective date
2021-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:41

Label at a glance#

ProductRoosin Neomycin Antibiotic
Active ingredientNEOMYCIN SULFATE
Label structure8 sections

Dosage and administration

Clean affected area Apply a small amount 1-3 times daily May cover with a sterile bandage

Storage and handling

Store at room temperatuure

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin Sulfate 0.556%

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Use

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor cuts scrapes burns

WARNINGS

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • In eyes
  • Over large areas of the body
  • For more than one week unless directed by a doctor
  • If you are allergic to any of the ingredients

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use an ask a doctor if 

  • A rash or allergic reaction develops
  • Condition worsens or persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If ingested, get medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Clean affected area

Apply a small amount 1-3 times daily

May cover with a sterile bandage

Other information

STORAGE AND HANDLING SECTION

Store at room temperatuure

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2539291neomycin sulfate 0.556 % Topical OintmentPSN2
2539291neomycin sulfate 0.00556 MG/MG Topical OintmentSCD2
2539291neomycin sulfate 0.556 % Topical OintmentSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81552-001-012023-01-30C16284748780-1f386c64a-3b91-0266-e053-dadaa90a7c1a81552-001 Neomycin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81552-001-01Roosin Neomycin Antibiotic0.9 g in 1 TUBEOINTMENT0.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81552-001ROOSIN NEOMYCIN ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [ROOSIN MEDICAL CO., LTD]2Legacy NDC, 1 package rows20211216_dd7ac04c-815c-4ad0-904e-86a3bea11f29.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81552-00181552-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
PARAFFINI9O0E3H2ZEIACT
OCTADECANOL (MIXTURE OF ISOMERS)C6BPY2QY39IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
GLYCEROL FORMAL3L7GR2604EIACT
NEOMYCIN SULFATE057Y626693ACTIM

Source Document#

Source XML

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
d3326023-81e3-4a7a-e053-2995a90ae579dd7ac04c-815c-4ad0-904e-86a3bea11f292021-12-15WarningsExact identifier
spl id: d3326023-81e3-4a7a-e053-2995a90ae579
spl set id: dd7ac04c-815c-4ad0-904e-86a3bea11f29

Reported adverse events (FAERS/openFDA)#

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