FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Yiwu Pharmacy Ecomm Business Enterprise Ltd
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:26

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

- A hand sanitizer to help reduce bacteria on the skin

Dosage and administration

Place enough to cover both hands in the palm, and rub hands together until dry. Children under 6 years of age should be supervised by adult when applying this product.

Storage and handling

Store below 110 ​o F (43 ​o ​C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses:

INDICATIONS & USAGE SECTION

- A hand sanitizer to help reduce bacteria on the skin

Warnings:

WARNINGS SECTION

For External Use Only.

SPL UNCLASSIFIED SECTION

Flammable.  Keep away from fire or flame or sparks

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash appears on the skin

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get immediate help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Place enough to cover both hands in the palm, and rub hands together until dry.
  • Children under 6 years of age should be supervised by adult when applying this product.

Other information.

STORAGE AND HANDLING SECTION

  • Store below 110 ​oF (43 ​o​C)
  • May discolor certain fabrics or surfaces.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified water, Carbomer 940, PEG12 - dimethicone, Propylene glycol, Aloe barbadensis leaf extract, Triethanolamine, Fragrance

​Package Labeling: 74649-000-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59mL59mL

Package Labeling:74649-000-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236mL236mL

Package Labeling:74649-000-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:74649-000-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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
74649-000-012022-01-28C16284748780-1d6a99b39-89cb-a426-e053-dadaa90af4c2Hand Sanitizer
74649-000-022022-01-28C16284748780-1d6a99b39-89cb-a426-e053-dadaa90af4c2Hand Sanitizer
74649-000-082022-01-28C16284748780-1d6a99b39-89cb-a426-e053-dadaa90af4c2Hand Sanitizer
74649-000-162022-01-28C16284748780-1d6a99b39-89cb-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74649-000-01Hand Sanitizer29 mL in 1 BOTTLEGEL292
74649-000-02Hand Sanitizer59 mL in 1 BOTTLEGEL592
74649-000-08Hand Sanitizer236 mL in 1 BOTTLEGEL2362
74649-000-16Hand Sanitizer473 mL in 1 BOTTLEGEL4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74649-000HAND SANITIZER (ALCOHOL) GEL [YIWU PHARMACY ECOMM BUSINESS ENTERPRISE LTD]2Legacy NDC, 4 package rows20200423_a3367e77-df3d-80d0-e053-2a95a90a66ec.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74649-00074649-000-02, 74649-000-08, 74649-000-01, 74649-000-16

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
CARBOMER 9404Q93RCW27EIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
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
a3dea52a-d297-9e06-e053-2995a90afce6a3367e77-df3d-80d0-e053-2a95a90a66ec2020-04-22WarningsExact identifier
spl id: a3dea52a-d297-9e06-e053-2995a90afce6
spl set id: a3367e77-df3d-80d0-e053-2a95a90a66ec

Reported adverse events (FAERS/openFDA)#

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