FDA.reportPublic FDA data

Antibacterial Hand Wipes

Manufacturer
American Exchange Time Llc | Zhejiang Jiayan Daily Commodity Co., Ltd.
Effective date
2020-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:48

Label at a glance#

ProductAntibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Apply to hands, allow to dry without wiping.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor fabrics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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 irritation or rash occurs. These may be signs of a serious condition.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation 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.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Disodium EDTA, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 Wipes in 1 BAG NDC: 78870-002-01 Package LabelPackage Label

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40 Wipes in 1 BAG NDC: 78870-002-02 Package LabelPackage Label

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
78870-002-012022-01-28C16284748780-1d6a99b39-4586-a426-e053-dadaa90af4c2acd1b9bb-f6a5-d1ff-e053-2995a90a8dcf
78870-002-022022-01-28C16284748780-1d6a99b39-4586-a426-e053-dadaa90af4c2acd1b9bb-f6a5-d1ff-e053-2995a90a8dcf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78870-002-01Antibacterial Hand Wipes70 g in 1 BAGCLOTH701
78870-002-02Antibacterial Hand Wipes185 g in 1 BAGCLOTH1851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78870-002ANTIBACTERIAL HAND WIPES (HAND SANITIZER) CLOTH [AMERICAN EXCHANGE TIME LLC]1Legacy NDC, 2 package rows20200815_acd1b9bb-f6a5-d1ff-e053-2995a90a8dcf.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78870-00278870-002-01, 78870-002-02

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
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
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
acd17774-d1ad-c136-e053-2a95a90a6002acd1b9bb-f6a5-d1ff-e053-2995a90a8dcf2020-08-14WarningsExact identifier
spl id: acd17774-d1ad-c136-e053-2a95a90a6002
spl set id: acd1b9bb-f6a5-d1ff-e053-2995a90a8dcf

Reported adverse events (FAERS/openFDA)#

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