FDA.reportPublic FDA data

BIOPURE 250CT ANTI BACTERIAL HAND WIPES

Manufacturer
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:18:03

Label at a glance#

ProductBIOPURE 250CT ANTI BACTERIAL HAND WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure14 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， between 15°-30°C（59°F-86°F). ●Avoid freezing and excessive heat above 40°C（104°F）.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12% ……………………………………………...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， between 15°-30°C（59°F-86°F).

●Avoid freezing and excessive heat above 40°C（104°F）.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Phenoxyethanol, Propylene Glycol, Water

Question?

POSTMARKETING EXPERIENCE SECTION

Call 718-975-2586

79794-900-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

900-01900-01

79794-900-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79794-900-0279794-900-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN3
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD3
1038741benzalkonium chloride 0.12 % Medicated WipeSY3
1038741benzalkonium chloride 0.12 % Topical ClothSY3
1038741benzalkonium chloride 0.12 % Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79794-900-012024-02-01C16284748780-11030e365-5c7f-111a-e063-dadaa90a10e279794-900

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79794-900-01BIOPURE 250CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH13
79794-900-01BIOPURE 250CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH123
79794-900-02BIOPURE 250CT ANTI BACTERIAL HAND WIPES6 in 1 CANISTERCLOTH63
79794-900-02BIOPURE 250CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79794-900BIOPURE 250CT ANTI BACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [ZHEJIANG FURUISEN SPUNLACED NONWOVENS CO., LTD.]3Legacy NDC, 4 package rows20240829_ee48c7f1-04ad-1663-e053-2995a90ae41e.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79794-90079794-900-01, 79794-900-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
20baf202-0af1-8596-e063-6294a90a0e10ee48c7f1-04ad-1663-e053-2995a90ae41e2024-08-28WarningsExact identifier
spl id: 20baf202-0af1-8596-e063-6294a90a0e10
spl set id: ee48c7f1-04ad-1663-e053-2995a90ae41e

Reported adverse events (FAERS/openFDA)#

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