FDA.reportPublic FDA data

Soapbox Antibacterial Hand Wipes

Manufacturer
DYNAMIC WIPE INDUSTRIES LTD.
Effective date
2020-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:39

Label at a glance#

ProductSoapbox Antibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

Throughly wipe hands with cloth Rub hands together until dry No rinsing required

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin. For use when soap and water not available.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid getting into the eyes.
  • In case of eye contact immediately flush eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation or redness develops
  • Condition persist for more than 72 hours
  • Redness is present

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Throughly wipe hands with cloth
  • Rub hands together until dry
  • No rinsing required

Other information

SPL UNCLASSIFIED SECTION

  • Dispose of properly, do not flush.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Polysorbate 20, Glycerin, Potassium Sorbate, Aloe (Aloe Barbadensis) Leaf Extract, Dehydroacetic Acid, Phenoxyethanol, Citric Acid

Package Labeling:20wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:50wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:400wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77645-004-012024-01-30C16284748780-11030e365-3ff3-111a-e063-dadaa90a10e2Soapbox Antibacterial Hand Wipes
77645-004-022024-01-30C16284748780-11030e365-3ff3-111a-e063-dadaa90a10e2Soapbox Antibacterial Hand Wipes
77645-004-032024-01-30C16284748780-11030e365-3ff3-111a-e063-dadaa90a10e2Soapbox Antibacterial Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77645-004-01Soapbox Antibacterial Hand Wipes20 in 1 PACKAGECLOTH201
77645-004-01Soapbox Antibacterial Hand Wipes3 mL in 1 PATCHCLOTH31
77645-004-02Soapbox Antibacterial Hand Wipes3 mL in 1 PATCHCLOTH31
77645-004-02Soapbox Antibacterial Hand Wipes50 in 1 PACKAGECLOTH501
77645-004-03Soapbox Antibacterial Hand Wipes3 mL in 1 PATCHCLOTH31
77645-004-03Soapbox Antibacterial Hand Wipes400 in 1 CANISTERCLOTH4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77645-004SOAPBOX ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [DYNAMIC WIPE INDUSTRIES LTD.]1Legacy NDC, 6 package rows20201015_b0246c16-c61b-29d9-e053-2995a90a0210.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
77645-00477645-004-01, 77645-004-02, 77645-004-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALOE VERA LEAFZY81Z83H0XIACT
DEHYDROACETIC ACID2KAG279R6RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
b0246c16-c61c-29d9-e053-2995a90a0210b0246c16-c61b-29d9-e053-2995a90a02102020-09-25WarningsExact identifier
spl id: b0246c16-c61c-29d9-e053-2995a90a0210
spl set id: b0246c16-c61b-29d9-e053-2995a90a0210

Reported adverse events (FAERS/openFDA)#

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