FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Zhejiang iColor Biotech Co., Ltd | WESSCO International
Effective date
2021-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:08

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Squeeze a significant amount in your palm and rub hands until fully dry. Rinse free.

Storage and handling

Store below 110 °F（43° C).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce germs on the skin.

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable: Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop using and ask a doctor if irritation or redness develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Squeeze a significant amount in your palm and rub hands until fully dry.
  • Rinse free.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110 °F（43° C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL NDC: 74934-030-01 59ml label59ml label

5000 mL NDC: 74934-030-03 5000ml label5000ml label 5000ml label5000ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74934-030-012022-07-29C16284748780-1e4f33bdf-abdc-d8a0-e053-dadaa90a6e4eZhejiang iColor Biotech Co., Ltd Hand Sanitizer 59ml 1000ml
74934-030-032022-07-29C16284748780-1e4f33bdf-abdc-d8a0-e053-dadaa90a6e4eZhejiang iColor Biotech Co., Ltd Hand Sanitizer 59ml 1000ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74934-030-01Hand Sanitizer59 mL in 1 BOTTLEGEL592
74934-030-03Hand Sanitizer5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74934-030HAND SANITIZER (ALCOHOL) GEL [ZHEJIANG ICOLOR BIOTECH CO., LTD]2Legacy NDC, 2 package rows20210121_ab0866b5-11d3-317b-e053-2995a90aa0d9.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74934-03074934-030-01, 74934-030-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
DENATONIUM BENZOATE4YK5Z54AT2IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MALTODEXTRIN7CVR7L4A2DIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

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
b956cf10-5a95-0992-e053-2a95a90aeaf7ab0866b5-11d3-317b-e053-2995a90aa0d92021-01-20WarningsExact identifier
spl id: b956cf10-5a95-0992-e053-2a95a90aeaf7
spl set id: ab0866b5-11d3-317b-e053-2995a90aa0d9

Reported adverse events (FAERS/openFDA)#

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