FDA.reportPublic FDA data

ANTIBACTERIAL WIPES UNSCENTED

Manufacturer
ZHANGZHOU WANSIKE ELECTRONICS CO., LTD
Effective date
2020-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:44

Label at a glance#

ProductANTIBACTERIAL WIPES UNSCENTED
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Storage and handling

keep containers tightly closed in a dry, cool and well-ventilated place. recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease

Warnings

WARNINGS SECTION

For external use only

When using this product
keep out of eyes.In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin

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

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

Control Center right away.

Do not use

OTC - DO NOT USE SECTION

/

OTC - WHEN USING SECTION

keep out of eyes.In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin

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

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 and redness develop
condition 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Other information

STORAGE AND HANDLING SECTION

keep containers tightly closed in a dry, cool and well-ventilated place.
recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, phenoxyethanol, polysorbate 20, propylene glycol,

tocopheryl acetate, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80593-003-04 70P80593-003-04 70P80593-003-06 100P80593-003-06 100P80593-003-02 20P80593-003-02 20P80593-003-08 300P80593-003-08 300P80593-003-07 160P80593-003-07 160P80593-003-10 800P80593-003-10 800P80593-003-09 500P80593-003-09 500P80593-003-03 50P80593-003-03 50P80593-003-05 80P80593-003-05 80P80593-003-01 10P80593-003-01 10P

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80593-003-012022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-022022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-032022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-042022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-052022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-062022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-072022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-082022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-092022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED
80593-003-102022-01-28C16284748780-1d6a99b39-cc3c-a426-e053-dadaa90af4c280593-003 ANTIBACTERIAL WIPES UNSCENTED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80593-003-01ANTIBACTERIAL WIPES UNSCENTED10 in 1 PACKAGESOLUTION102
80593-003-02ANTIBACTERIAL WIPES UNSCENTED20 in 1 PACKAGESOLUTION202
80593-003-03ANTIBACTERIAL WIPES UNSCENTED50 in 1 PACKAGESOLUTION502
80593-003-04ANTIBACTERIAL WIPES UNSCENTED70 in 1 PACKAGESOLUTION702
80593-003-05ANTIBACTERIAL WIPES UNSCENTED80 in 1 CANISTERSOLUTION802
80593-003-06ANTIBACTERIAL WIPES UNSCENTED100 in 1 CANISTERSOLUTION1002
80593-003-07ANTIBACTERIAL WIPES UNSCENTED160 in 1 CANISTERSOLUTION1602
80593-003-08ANTIBACTERIAL WIPES UNSCENTED300 in 1 CANISTERSOLUTION3002
80593-003-09ANTIBACTERIAL WIPES UNSCENTED500 in 1 CANISTERSOLUTION5002
80593-003-10ANTIBACTERIAL WIPES UNSCENTED800 in 1 CANISTERSOLUTION8002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80593-003ANTIBACTERIAL WIPES UNSCENTED (BENZALKONIUM CHLORIDE) SOLUTION [ZHANGZHOU WANSIKE ELECTRONICS CO., LTD]2Legacy NDC, 10 package rows20201102_b2f057ca-e7c6-3c9f-e053-2a95a90a3337.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
80593-00380593-003-01, 80593-003-03, 80593-003-02, 80593-003-04, 80593-003-05, 80593-003-08, 80593-003-07, 80593-003-09, 80593-003-06, 80593-003-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
b3168a34-bd68-ba8a-e053-2995a90ab9dbb2f057ca-e7c6-3c9f-e053-2a95a90a33372020-11-01WarningsExact identifier
spl id: b3168a34-bd68-ba8a-e053-2995a90ab9db
spl set id: b2f057ca-e7c6-3c9f-e053-2a95a90a3337

Reported adverse events (FAERS/openFDA)#

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