Colemerg Antibacterial Hand Sanitizing Wipes

Manufacturer
Colemerg Products LLC
Effective date
2020-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:23

Label at a glance#

ProductColemerg Antibacterial Hand Sanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

Remove lid and open the seal. Pull up the corner of the center sheet, twist it and thread through the dispenser slipt in the lid. Pull sheet out at an angle. When finished close lid flap to retain moisure.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13 % w/v

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

Over large areas of the body if you are allegic to any of the ingredients.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Remove lid and open the seal.
  • Pull up the corner of the center sheet, twist it and thread through the dispenser slipt in the lid.
  • Pull sheet out at an angle. When finished close lid flap to retain moisure.

Other Information:

SPL UNCLASSIFIED SECTION

  • Do not expose to direct sunlight, preferably place them in a cool place
  • Do not use on furniture
  • Do not flush down toilets, dispose in trash can

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua/Water, Glycerin, Phenoxyethanol, Parfum/Fragrance, Polysorbate 20, Sodium PCA, Tetrasodium Edta, Ethylhexylglycerin, Citric Acid.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
80171-001-002022-01-28C16284748780-1d6a99b39-988c-a426-e053-dadaa90af4c2Colemerg Antibacterial Hand Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80171-001-00Colemerg Antibacterial Hand Sanitizing Wipes3.2 g in 1 PATCHCLOTH3.23
80171-001-00Colemerg Antibacterial Hand Sanitizing Wipes100 in 1 BAGCLOTH1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80171-001COLEMERG ANTIBACTERIAL HAND SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [COLEMERG PRODUCTS LLC]3Legacy NDC, 2 package rows20201112_ad528181-90aa-57cf-e053-2a95a90ad600.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
80171-00180171-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
b3d6e73b-1ffc-4e7f-e053-2a95a90ac1e7ad528181-90aa-57cf-e053-2a95a90ad6002020-11-11WarningsExact identifier
spl id: b3d6e73b-1ffc-4e7f-e053-2a95a90ac1e7
spl set id: ad528181-90aa-57cf-e053-2a95a90ad600

Reported adverse events (FAERS/openFDA)#

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