FDA.reportPublic FDA data

0498-0402 & 0498-0401: Antiseptic Spray

Manufacturer
Honeywell Safety Products USA, Inc
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:13:01

Label at a glance#

ProductAntiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

clean the affected area spray a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

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 or near 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

When using this product

OTC - WHEN USING SECTION

do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse

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
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

OTHER SAFETY INFORMATION

  • shake well
  • store at room temperature 15 o-30 o C (59 o-86 o F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

Questions

OTC - QUESTIONS SECTION

1-800-430-5490

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

antiseptic sprayantiseptic spray

Honeywell Antiseptic Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Honeywell Antiseptic sprayHoneywell Antiseptic spray

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0498-04020498-0402-59
0498-04010498-0401-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OCTOXYNOL 97JPC6Y25QSIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
OCTOXYNOL 97JPC6Y25QSIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
1a169120-f6d6-f06a-e063-6394a90ab9c86002c37b-74fc-1754-e053-2991aa0af12e2024-06-04WarningsExact identifier
spl set id: 6002c37b-74fc-1754-e053-2991aa0af12e

Reported adverse events (FAERS/openFDA)#

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