FDA.reportPublic FDA data

Antiseptic Towelette

Manufacturer
Sled Distribution, LLC
Effective date
2022-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:20

Label at a glance#

ProductAntiseptic Towelette
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Open packet, unfold and use as a washcloth. Single use only.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

USE

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacterica on the skin. Signle use only.

Warning

WARNINGS SECTION

  • Flammable, keep away from fire or flame. 
  • For external use only.

Do not use 

  • in the eyes or apply over large areas of the body. 
  • Stop use and ask a doctor,
  • Irritaion , redness develop.
  • Condition persists or gets worse.

Other Information：

  • Store at room temperature,  15-30 ℃ or 59-86℉.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

●If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Open packet, unfold and use as a washcloth. Single use only.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81417-010-012024-01-30C16284748780-11030e365-1457-111a-e063-dadaa90a10e2MY MEDIC ANTISEPTIC TOWELETTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-010-01Antiseptic Towelette1.6 mL in 1 POUCHCLOTH1.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-010ANTISEPTIC TOWELETTE (BENZALKONIUM TOWELETTE) CLOTH [SLED DISTRIBUTION, LLC]1Legacy NDC, 1 package rows20221103_ec874e22-f255-7ca8-e053-2a95a90a3438.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-01081417-010-01

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

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
ec87c71a-5b0b-09e2-e053-2995a90a0182ec874e22-f255-7ca8-e053-2a95a90a34382022-11-02WarningsExact identifier
spl id: ec87c71a-5b0b-09e2-e053-2995a90a0182
spl set id: ec874e22-f255-7ca8-e053-2a95a90a3438

Reported adverse events (FAERS/openFDA)#

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