FDA.reportPublic FDA data

Hand Wipes

Manufacturer
Kareway Product, Inc.
Effective date
2020-09-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:26:53

Label at a glance#

ProductHand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

adults and children 2 years and over apply to hands allow to dry without wiping Children under 2 years ask a doctor before use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

decrease bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION

do not get into eyes. If contact occurs, rinse throroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash develops and continues for more than 72 hours

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

adults and children 2 years and over

  • apply to hands
  • allow to dry without wiping

Children under 2 years

  • ask a doctor before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol, Cocamidopropyl Betaine, Phenoxyethanol, Propylene Glycol, Disodium EDTA, Fragrance, Butylene Glycol, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Origanum Vulgare Flower/Leaf/Stem Extract, Thymus Vulgaris (Thyme) Extract, Camellia Sinensis Leaf Extract

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fresh Scent

Wet wiptes

Antibacterial formula

30 wipes

pouchpouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-1888-22021-07-23C16284748780-1c7ccaba7-18ab-fd44-e053-dadaa90aa01bPure-Aid Hand Wipes
67510-1888-32021-07-23C16284748780-1c7ccaba7-18ab-fd44-e053-dadaa90aa01bPure-Aid Hand Wipes
67510-1888-42021-07-23C16284748780-1c7ccaba7-18ab-fd44-e053-dadaa90aa01bPure-Aid Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-1888-2Hand Wipes24 in 1 PACKETSWAB243
67510-1888-3Hand Wipes30 in 1 POUCHSWAB303
67510-1888-4Hand Wipes40 in 1 CANISTERSWAB403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-1888HAND WIPES (BENZALKONIUM CHLORIDE) SWAB [KAREWAY PRODUCT, INC.]3Legacy NDC, 3 package rows20200905_a0fdd16c-fdcd-73b3-e053-2995a90a4ae5.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-188867510-1888-3, 67510-1888-2, 67510-1888-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ORIGANUM VULGARE SUBSP. HIRTUM FLOWER3799SP11NYIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAVANDULA ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
ROSEMARYIJ67X351P9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
THYMECW657OBU4NIACT

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
ae81ade6-5e5a-bc6a-e053-2a95a90a8332a0fdd16c-fdcd-73b3-e053-2995a90a4ae52020-09-04WarningsExact identifier
spl id: ae81ade6-5e5a-bc6a-e053-2a95a90a8332
spl set id: a0fdd16c-fdcd-73b3-e053-2995a90a4ae5

Reported adverse events (FAERS/openFDA)#

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