FDA.reportPublic FDA data

Hand Wipes

Manufacturer
Harmon Stores Inc. | Precare Corp.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:58

Label at a glance#

ProductHand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

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

Storage and handling

Store at room temperature keep closed tightly may discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride.........0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

​Do not use if you are allergic to any of these ingredients

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation or redness develops, or if condition persists 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 (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and childrens 2 years and over: apply to hands, allow to dry without wiping
  • children under 2 years: ask a doctor before use   

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature
  • keep closed tightly
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 63940-036-36

Compare to Purell ®​ Hand Sanitizing Wipes

36 hand wipes

CORE VALUES TM​antibacterial 

Hand Wipes

KILLS 99.9% of germs

Clean Scent

Perfect for Travel

36 - Wet Hand Wipes

5.7 in. x 7.5 in. (14.5cm x 19.1cm)

LabelLabel

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
63940-036-362024-12-16C16284748780-1f386c649-e720-0266-e053-dadaa90a7c1aDrug Facts
63940-036-362023-01-30C16284748780-1f386c649-e720-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-036-36Hand Wipes0.13 g in 1 PACKETSWAB0.134
63940-036-36Hand Wipes36 in 1 PACKAGESWAB364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-036HAND WIPES (BENZALKONIUM CHLORIDE) SWAB [HARMON STORES INC.]4Legacy NDC, 2 package rows20241218_8f2c1911-6643-4c8f-9ea9-97a16910c6c9.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
63940-03663940-036-36

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
PHENOXYETHANOLHIE492ZZ3TIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
296b4479-42ec-929c-e063-6394a90a85c18f2c1911-6643-4c8f-9ea9-97a16910c6c92024-12-16WarningsExact identifier
spl id: 296b4479-42ec-929c-e063-6394a90a85c1
spl set id: 8f2c1911-6643-4c8f-9ea9-97a16910c6c9

Reported adverse events (FAERS/openFDA)#

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