FDA.reportPublic FDA data

Antibacterial Hand Wipes

Manufacturer
Osike Cosmetics Co., Ltd.
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:15

Label at a glance#

ProductAntibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

●Apply to hands, allow to air dry without wiping. ●Children under 6 years of age should be supervised when using this product

Storage and handling

●Store in a cool, dry place. ●Avoid freezing and excessive heat.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Use

INDICATIONS & USAGE SECTION

●Hand sanitizer to help reduce bacteria
●For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use
●in children less than 2 months old.
●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 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.

Do not use

OTC - DO NOT USE SECTION

●in children less than 2 months old.
●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 air dry without wiping.
●Children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

●Store in a cool, dry place.
●Avoid freezing and excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79866-008-01 75P79866-008-01 75P

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79866-008-012024-01-30C16284748780-11030e365-07d5-111a-e063-dadaa90a10e279866-008 Antibacterial Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79866-008-01Antibacterial Hand Wipes75 in 1 DRUMCLOTH752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79866-008ANTIBACTERIAL HAND WIPES (WIPES) CLOTH [OSIKE COSMETICS CO., LTD.]2Legacy NDC, 1 package rows20220120_af6589f9-3b0b-7548-e053-2995a90a4ddf.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79866-00879866-008-01

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
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
d5fe93b2-60e1-ab20-e053-2995a90a0630af6589f9-3b0b-7548-e053-2995a90a4ddf2022-01-20WarningsExact identifier
spl id: d5fe93b2-60e1-ab20-e053-2995a90a0630
spl set id: af6589f9-3b0b-7548-e053-2995a90a4ddf

Reported adverse events (FAERS/openFDA)#

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