FDA.reportPublic FDA data

Color Element Alcohol Free Hand Sanitizer

Manufacturer
Zhejiang iColor Biotech Co., Ltd
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:12:47

Label at a glance#

ProductColor Element Alcohol Free Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.

Dosage and administration

●Place enough product on hands to cover all surfaces. Rub hands together until dry. ●Children under 6 years of age should be supervised by adult when applying this product. ●Do not use on children less than 2 months of age or on open skin wounds.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in or near eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears on the skin.

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

●Place enough product on hands to cover all surfaces. Rub hands together until dry.
●Children under 6 years of age should be supervised by adult when applying this product.
●Do not use on children less than 2 months of age or on open skin wounds.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Polyquaternium-37,Didecyldimonium Chloride,Polyaminopropyl Biguanide, Aloe Barbadensis Leaf Water, Fragrance, Phenoxyethanol.

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box4Box4

Package Labeling:2ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74934-048COLOR ELEMENT ALCOHOL FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ZHEJIANG ICOLOR BIOTECH CO., LTD]3Legacy NDC20240125_ee223389-0a31-40bd-bca9-978283db5994.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74934-04874934-048-01, 74934-048-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
0fb3b0d8-393b-a274-e063-6394a90aa3a5ee223389-0a31-40bd-bca9-978283db59942024-01-24WarningsExact identifier
spl id: 0fb3b0d8-393b-a274-e063-6394a90aa3a5
spl set id: ee223389-0a31-40bd-bca9-978283db5994

Reported adverse events (FAERS/openFDA)#

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