FDA.reportPublic FDA data

ANTISEPTIC WIPE

Manufacturer
Total Resources International Inc.
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:38:51

Label at a glance#

ProductANTISEPTIC WIPE 01
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Tear open packet, unfold and use as a washcloth Allow hands to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes. If this happens, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor If irritation or redness develops and persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Tear open packet, unfold and use as a washcloth
  • Allow hands to dry without wiping

Inactive ingredient

INACTIVE INGREDIENT SECTION

water

Antiseptic Wipe

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic WipeAntiseptic Wipe

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN9
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD9
1038558benzalkonium chloride 0.13 % Topical ClothSY9
1038558benzalkonium chloride 0.13 % Topical SwabSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY9
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-221-012023-02-01C16284748780-1f386c649-c9fc-0266-e053-dadaa90a7c1aDrug Facts
55550-221-012023-02-01C16284748780-1f386c649-c9fc-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-221-01ANTISEPTIC WIPE011.6 g in 1 PATCHPATCH1.69

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
55550-22155550-221-01

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
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-12-20full-release2026-06-01 00:50:09

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
ANTISEPTIC WIPE 01BENZALKONIUM CHLORIDETotal Resources International Inc.cf4a6a97-529e-7f11-e053-2a95a90a75a92025-10-10WarningsExact identifier
ndc (package): 55550-221-01
ndc (product): 55550-221
ndc11 (package): 55550022101
spl id: b36d050b-cde5-42ec-b26d-9e165c8a0630
spl set id: cf4a6a97-529e-7f11-e053-2a95a90a75a9

Reported adverse events (FAERS/openFDA)#

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