KOLMED HAND SANITIZING WIPES

Manufacturer
Passhion Inc
Effective date
2020-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:37

Label at a glance#

ProductKOLMED HAND SANITIZING WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

• hand wipes to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing • discard wipe in trash after use. Do not flush

Storage and handling

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.2%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand wipes to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Warnings

WARNINGS SECTION

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water. Do not inhale

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

• discard wipe in trash after use. Do not flush

Other information

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)

• avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe vera (Aloe barbadensis) leaf juice, citric acid, decyl glucoside, ethylhexylglycerin,

fragrance, glycerin, phenoxyethanol, polysorbate 20, potassium sorbate, sodium benzoate,tocopheryl acetate, water

SPL UNCLASSIFIED SECTION

3X STRONGER

Kills 99% OF COMMON GERMS*

COTTONY SOFT

NON-ALCOHOL FORMULA

Crisp Orange

GENTLE ON HANDS

EXTRA SOFT WIPE WITH ALOE

√ Kills 99% of many common harmful germs and bacteria*

√ Removes light soils and dirt from hands

√ Gentle on hands

√ Multi-layered Wipe. 3X Stronger vs. Paper Towel1

TO OPEN PACKAGE:

1. Pull out wipe from center of roll.

2. Next sheet pops up automatically.

3. Close lid to retain moisture.

STORAGE AND DISPOSAL:

Dispose of wipe in trash after use. Do not flush. Tightly close lid between uses to retain moisture.

Non refillable container. Do not reuse or refill this empty container.

Offer empty container for recycling. If recycling is not available, discard container in trash.

Questions or Comments?

Please visit www.kolmedusa.com.

Mon-Fri 9AM-6PM PST

Distributed by:

Passhion Inc

3192 Factory Dr, Pomona, CA, 91768

KOLMED is a registered trademark of Passhion Inc

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360919benzalkonium Cl 0.2 % Medicated PadPSN1
2360919benzalkonium chloride 2 MG/ML Medicated PadSCD1
2360919benzalkonium chloride 0.2 % Medicated WipeSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79517-001-012022-01-28C16284748780-1d6a99b39-45c4-a426-e053-dadaa90af4c2KOLMED HAND SANITIZING WIPES
79517-001-022022-01-28C16284748780-1d6a99b39-45c4-a426-e053-dadaa90af4c2KOLMED HAND SANITIZING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79517-001-01KOLMED HAND SANITIZING WIPES4.41 g in 1 PACKAGECLOTH4.411
79517-001-01KOLMED HAND SANITIZING WIPES85 in 1 CANISTERCLOTH851
79517-001-02KOLMED HAND SANITIZING WIPES85 in 1 CANISTERCLOTH851
79517-001-02KOLMED HAND SANITIZING WIPES4 in 1 BOXCLOTH41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79517-001KOLMED HAND SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [PASSHION INC]1Legacy NDC, 4 package rows20200903_2e3c0957-45c6-4f51-83fa-11d86763e90a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79517-00179517-001-01, 79517-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
c5c5d797-0ee9-4d28-9bfe-7a876fd1bf502e3c0957-45c6-4f51-83fa-11d86763e90a2020-08-17WarningsExact identifier
spl id: c5c5d797-0ee9-4d28-9bfe-7a876fd1bf50
spl set id: 2e3c0957-45c6-4f51-83fa-11d86763e90a

Reported adverse events (FAERS/openFDA)#

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