FDA.reportPublic FDA data

Neomycin

Manufacturer
Honeywell Safety Products USA, Inc
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:13:00

Label at a glance#

ProductNeomycin
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 the 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 (each gram contains)

OTC - ACTIVE INGREDIENT SECTION

Neomycin sulfate (5 mg 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
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • 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
  • you need to use longer than 1 week

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of the 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 15 o to 25 oC (59 o to 77 oF)

Inactive ingredient

INACTIVE INGREDIENT SECTION

petrolatum

Questions?

OTC - QUESTIONS SECTION

1-800-430-5490

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeomycinNeomycin

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0498-07300498-0730-01, 0498-0730-05

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
PETROLATUM4T6H12BN9UIACT
NEOMYCIN SULFATE057Y626693ACTIB

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
1a1678f4-28b3-e226-e063-6394a90aaf345f864f6d-1b5c-5b24-e053-2a91aa0ae0dc2024-06-04WarningsExact identifier
spl set id: 5f864f6d-1b5c-5b24-e053-2a91aa0ae0dc

Reported adverse events (FAERS/openFDA)#

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