FDA.reportPublic FDA data

BIOPURE ANTIBACTERIAL HAND WIPES

Manufacturer
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Effective date
2024-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:53:49

Label at a glance#

ProductBIOPURE ANTIBACTERIAL HAND WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

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

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

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12 %

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

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

OTC - DO NOT USE SECTION

●in children less than 2 months of age.

●on open skin wounds.

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Water, Glycerin, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Didecyldimonium Chloride

79794-113

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79794-113-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79794-113BIOPURE ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) PATCH [ZHEJIANG FURUISEN SPUNLACED NONWOVENS CO., LTD.]1Unmatched20241001_235174f3-26bb-2f08-e063-6394a90a1a20.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
79794-11379794-113-01

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
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT

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
36bb464e-38b1-55a4-e063-6394a90a54c5235174f3-26bb-2f08-e063-6394a90a1a202025-06-04WarningsExact identifier
spl set id: 235174f3-26bb-2f08-e063-6394a90a1a20

Reported adverse events (FAERS/openFDA)#

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