FDA.reportPublic FDA data

Antibacterial Hand Wipes

Manufacturer
AMERICAN EXCHANGE TIME LLC | Kangna (Zhejiang) Medical Supplies Co., Ltd.
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:41

Label at a glance#

ProductAntibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure5 sections

Dosage and administration

Apply to hands, allow to dry without wiping. .

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13 %

Purpose

OTC - PURPOSE SECTION

Antimicrobial Agent

USE

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap
and water are not available.

Warning

WARNINGS SECTION

For external use only. Do not use:
●In children less than 2 months of age.
●On open skin wounds.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes,
rinse eyes thoroughly with water.
Stop use and ask a doctor if iritation or rash occurs. These may be signs of a serious
condition.

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 right away. .

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to hands, allow to dry without wiping. .

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
78870-901-012022-01-28C16284748780-1d6a99b39-f67a-a426-e053-dadaa90af4c278870-901 Antibacterial Hand Wipes 0.13% Benzalkonium Chloride
78870-901-022022-01-28C16284748780-1d6a99b39-f67a-a426-e053-dadaa90af4c278870-901 Antibacterial Hand Wipes 0.13% Benzalkonium Chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78870-901-01Antibacterial Hand Wipes420 g in 1 POUCHCLOTH4201
78870-901-01Antibacterial Hand Wipes80 in 1 BAGCLOTH801
78870-901-02Antibacterial Hand Wipes82 g in 1 POUCHCLOTH821
78870-901-02Antibacterial Hand Wipes15 in 1 BAGCLOTH151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78870-901ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [AMERICAN EXCHANGE TIME LLC]1Legacy NDC, 4 package rows20200623_a8b5bc16-8203-dfc7-e053-2a95a90a524e.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78870-90178870-901-01, 78870-901-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POLYSORBATE 207T1F30V5YHIACT

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
a8b5a9b6-fb28-a631-e053-2a95a90a7ad3a8b5bc16-8203-dfc7-e053-2a95a90a524e2020-06-22WarningsExact identifier
spl id: a8b5a9b6-fb28-a631-e053-2a95a90a7ad3
spl set id: a8b5bc16-8203-dfc7-e053-2a95a90a524e

Reported adverse events (FAERS/openFDA)#

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