FDA.reportPublic FDA data

Antibacterial Wipes

Manufacturer
SHAOXING ELITE BIO-TECH CO.,LTD.
Effective date
2023-11-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:42

Label at a glance#

ProductAntibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Tear open the packet and remove wipe. Wet hands thoroughly with product and let hands air dry. Throw used wipe in trash. Do not flush.

Storage and handling

Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping. Children under 2 years. Consult a doctor prior to use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial Agent

Use

INDICATIONS & USAGE SECTION

Decreases bacteria on skin.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use if you are allergic to any of the ingredients.

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes and mouth. lf product gets in the eyes, flush thoroughly with water.

OTC - STOP USE SECTION

Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Tear open the packet and remove wipe.

Wet hands thoroughly with product and let hands air dry.

Throw used wipe in trash.

Do not flush.

Other information

STORAGE AND HANDLING SECTION

Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping.

Children under 2 years. Consult a doctor prior to use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Vitamin E, Aloe Barbadensis Leaf Juice, Aqua.

Antibacterial Wipes Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:81079-001-01

1010

NDC:81079-001-02

2020

​NDC:81079-001-03

4040

​NDC:81079-001-04

6060

​NDC:81079-001-05

8080

​NDC:81079-001-06

100100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81079-001-01Antibacterial Wipes38 g in 1 BAGCLOTH382
81079-001-02Antibacterial Wipes76 g in 1 BAGCLOTH762
81079-001-03Antibacterial Wipes153 g in 1 BAGCLOTH1532
81079-001-04Antibacterial Wipes230 g in 1 BAGCLOTH2302
81079-001-05Antibacterial Wipes307 g in 1 BAGCLOTH3072
81079-001-06Antibacterial Wipes384 g in 1 BAGCLOTH3842

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81079-001ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [SHAOXING ELITE BIO-TECH CO.,LTD.]2Current NDC, Legacy NDC, 6 package rows20231123_b41a4e86-38ec-4e6b-e053-2a95a90aabe8.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81079-00181079-001-01, 81079-001-02, 81079-001-03, 81079-001-04, 81079-001-05, 81079-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)G258TFN61XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
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
Antibacterial WipesBENZALKONIUM CHLORIDESHAOXING ELITE BIO-TECH CO.,LTD.b41a4e86-38ec-4e6b-e053-2a95a90aabe82023-11-22WarningsExact identifier
ndc (package): 81079-001-05
ndc (package): 81079-001-02
ndc (package): 81079-001-06
ndc (package): 81079-001-04
ndc (package): 81079-001-03
ndc (package): 81079-001-01
ndc (product): 81079-001
ndc11 (package): 81079000101
ndc11 (package): 81079000103
ndc11 (package): 81079000105
ndc11 (package): 81079000102
ndc11 (package): 81079000104
ndc11 (package): 81079000106
spl id: 0ab848b7-668f-4af1-e063-6294a90a5fc4
spl set id: b41a4e86-38ec-4e6b-e053-2a95a90aabe8

Reported adverse events (FAERS/openFDA)#

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