FDA.reportPublic FDA data

Biopure antibacterial hand wipe

Manufacturer
QUEST USA CORP.
Effective date
2024-02-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:08:35

Label at a glance#

ProductBiopure antibacterial hand wipe
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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 old.
  • on open skin wounds.

When using this product 

OTC - WHEN USING SECTION

do not get in eyes. If contact is made rinse thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Question?

OTC - QUESTIONS SECTION

call 718-975-2586

Package Labeling:1600ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:800ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:50ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN7
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD7
1038741benzalkonium chloride 0.12 % Medicated WipeSY7
1038741benzalkonium chloride 0.12 % Topical ClothSY7
1038741benzalkonium chloride 0.12 % Topical SwabSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78691-004-002025-07-29C16284748780-13b156c62-3088-fb37-e063-e6dba90a4e07Biopure antibacterial hand wipe
78691-004-012025-07-29C16284748780-13b156c62-3088-fb37-e063-e6dba90a4e07Biopure antibacterial hand wipe
78691-004-022025-07-29C16284748780-13b156c62-3088-fb37-e063-e6dba90a4e07Biopure antibacterial hand wipe
78691-004-032025-07-29C16284748780-13b156c62-3088-fb37-e063-e6dba90a4e07Biopure antibacterial hand wipe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-004-00Biopure antibacterial hand wipe1600 in 1 BAGCLOTH16007
78691-004-00Biopure antibacterial hand wipe3.44 mL in 1 PATCHCLOTH3.447
78691-004-01Biopure antibacterial hand wipe800 in 1 BAGCLOTH8007
78691-004-01Biopure antibacterial hand wipe3.25 mL in 1 PATCHCLOTH3.257
78691-004-02Biopure antibacterial hand wipe5.7 mL in 1 PATCHCLOTH5.77
78691-004-02Biopure antibacterial hand wipe50 in 1 POUCHCLOTH507
78691-004-03Biopure antibacterial hand wipe100 in 1 CANISTERCLOTH1007
78691-004-03Biopure antibacterial hand wipe5.37 mL in 1 PATCHCLOTH5.377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-004BIOPURE ANTIBACTERIAL HAND WIPE (BENZALKONIUM CHLORIDE) CLOTH [QUEST USA CORP.]7Legacy NDC, 8 package rows20240214_ad2b0d05-f0e1-2b6f-e053-2a95a90ac489.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
78691-00478691-004-00, 78691-004-01, 78691-004-02, 78691-004-03

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
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT

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
11343f80-34d3-6203-e063-6394a90a1c77ad2b0d05-f0e1-2b6f-e053-2a95a90ac4892024-02-12WarningsExact identifier
spl id: 11343f80-34d3-6203-e063-6394a90a1c77
spl set id: ad2b0d05-f0e1-2b6f-e053-2a95a90ac489

Reported adverse events (FAERS/openFDA)#

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