FDA.reportPublic FDA data

Hand sanitizer

Manufacturer
Zhejiang Tiaume Biotechnology Co., Ltd.
Effective date
2020-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:59

Label at a glance#

ProductHand sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6years of age when using this product to avoid swallowing.

Storage and handling

Store between 59-86F( 15-30C ) Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

ALCOHOL 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6years of age when using this product to avoid swallowing.

Warnings

WARNINGS SECTION

For external use only.Flammable.Keep away from fire or flame.

When use this product

Do not apply around eyes, ears &mouth. In cuse of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor lf irntation or rash occurs.These maybe signs of a serious condition.

Keep out of reach of children, Children must be supervised in use of this product.

Do not use

OTC - DO NOT USE SECTION

Do not apply around eyes, ears &mouth. In cuse of contact with eyes, rinse eyes thoroughly with water.

OTC - WHEN USING SECTION

When use this product

Do not apply around eyes, ears &mouth. In cuse of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor lf irntation or rash occurs.These maybe signs of a serious condition.

Keep out of reach of children, Children must be supervised in use of this product.

OTC - STOP USE SECTION

Stop use and ask a doctor lf irntation or rash occurs.These maybe signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store between 59-86F( 15-30C )
Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Propylene glycol,Triethanolamine,Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80915-001-01 300ML80915-001-01 300ML

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80915-001-012022-01-28C16284748780-1d6a99b39-b2c6-a426-e053-dadaa90af4c280915-001 Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80915-001-01Hand sanitizer300 mL in 1 BOTTLEGEL3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80915-001HAND SANITIZER GEL [ZHEJIANG TIAUME BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 1 package rows20201105_b344976e-7029-79e5-e053-2995a90aca02.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80915-00180915-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT

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
b344ad20-fce8-6ced-e053-2a95a90abde4b344976e-7029-79e5-e053-2995a90aca022020-11-04WarningsExact identifier
spl id: b344ad20-fce8-6ced-e053-2a95a90abde4
spl set id: b344976e-7029-79e5-e053-2995a90aca02

Reported adverse events (FAERS/openFDA)#

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