FDA.reportPublic FDA data

BIOPURE 50CT ANTI BACTERIAL HAND WIPES

Manufacturer
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Effective date
2025-02-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:31

Label at a glance#

ProductBIOPURE 50CT ANTI BACTERIAL HAND WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure18 sections

Indications and uses

●Hand sanitizer to help reduce bacteria

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 0.13% ……………………………………………...Antibacterial

Uses

INDICATIONS & USAGE SECTION

●Hand sanitizer to help reduce bacteria

OTC - PURPOSE SECTION

●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 old.

●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

OTC - STOP USE SECTION

if 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

STORAGE AND HANDLING SECTION

●Store in a cool, dry place.

●Avoid freezing and excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Question?

POSTMARKETING EXPERIENCE SECTION

Call 718-975-2586

79794-700-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

79794-700-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79794-700-0279794-700-02

79794-700-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79794-700-0379794-700-03

79794-700-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79794-700-0479794-700-04

79794-700-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​79794-700-05​79794-700-05

​79794-700-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​79794-700-06​79794-700-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD4
1038558benzalkonium chloride 0.13 % Topical ClothSY4
1038558benzalkonium chloride 0.13 % Topical SwabSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79794-700-012024-02-01C16284748780-11030e365-1d24-111a-e063-dadaa90a10e279794-700
79794-700-012024-01-30C16284748780-11030e365-1d24-111a-e063-dadaa90a10e279794-700

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79794-700-01BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH124
79794-700-01BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH14
79794-700-02BIOPURE 50CT ANTI BACTERIAL HAND WIPES40 in 1 POUCHCLOTH404
79794-700-02BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH244
79794-700-03BIOPURE 50CT ANTI BACTERIAL HAND WIPES40 in 1 POUCHCLOTH404
79794-700-03BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH124
79794-700-04BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH124
79794-700-04BIOPURE 50CT ANTI BACTERIAL HAND WIPES16 in 1 BOXCLOTH164
79794-700-05BIOPURE 50CT ANTI BACTERIAL HAND WIPES25 in 1 POUCHCLOTH254
79794-700-05BIOPURE 50CT ANTI BACTERIAL HAND WIPES8 in 1 CARTONCLOTH84
79794-700-06BIOPURE 50CT ANTI BACTERIAL HAND WIPES25 in 1 POUCHCLOTH254
79794-700-06BIOPURE 50CT ANTI BACTERIAL HAND WIPES8 in 1 CARTONCLOTH84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79794-700BIOPURE 50CT ANTI BACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [ZHEJIANG FURUISEN SPUNLACED NONWOVENS CO., LTD.]4Current NDC, Legacy NDC, 12 package rows20250207_ecef31dc-2f36-b578-e053-2995a90a3acd.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
79794-70079794-700-01, 79794-700-02, 79794-700-03, 79794-700-04, 79794-700-05, 79794-700-06

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
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.4fcf2c05-9bd2-2813-e063-6294a90a44012026-04-19WarningsExact identifier
ndc (product): 79794-700
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
ndc (package): 79794-700-05
ndc (package): 79794-700-03
ndc (package): 79794-700-06
ndc (package): 79794-700-02
ndc (package): 79794-700-04
ndc (package): 79794-700-01
ndc (product): 79794-700
ndc11 (package): 79794070002
ndc11 (package): 79794070001
ndc11 (package): 79794070004
ndc11 (package): 79794070003
ndc11 (package): 79794070006
ndc11 (package): 79794070005
spl id: 2d637b1f-5e12-efb1-e063-6394a90af6a8
spl set id: ecef31dc-2f36-b578-e053-2995a90a3acd

Reported adverse events (FAERS/openFDA)#

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