FDA.reportPublic FDA data

COLOR ELEMENT Antiseptic Hand Wipes

Manufacturer
Zhejiang iColor Biotech Co., Ltd
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:12:37

Label at a glance#

ProductCOLOR ELEMENT Antiseptic Hand Wipes
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

wet hands thoroughly with wipe and allow to dry without wiping

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only
Flammabe, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

wet hands thoroughly with wipe and allow to dry without wiping

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water

Questions or Comments?

OTC - QUESTIONS SECTION

212-551-2657

Package Label: 30 Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 Wipes Box Label30 Wipes Box Label

60ct Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ct Box Label60ct Box Label

50ct Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ct Bag Label50ct Bag Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74934-033COLOR ELEMENT ANTISEPTIC HAND WIPES (ALCOHOL) CLOTH [ZHEJIANG ICOLOR BIOTECH CO., LTD]3Legacy NDC20240125_4cb8239e-2f84-43c6-a229-86cc6e4d02bb.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74934-03374934-033-01, 74934-033-02, 74934-033-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
0fa07428-18bd-8397-e063-6294a90acabd4cb8239e-2f84-43c6-a229-86cc6e4d02bb2024-01-23WarningsExact identifier
spl id: 0fa07428-18bd-8397-e063-6294a90acabd
spl set id: 4cb8239e-2f84-43c6-a229-86cc6e4d02bb

Reported adverse events (FAERS/openFDA)#

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