FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Leads (China) Biotechnology Co., Ltd.
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:29:14

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 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%-75% v/v. Purpose: Antiseptic

PURPOSE

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

USE

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

WHEN USING

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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.
Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water(aqua), Glycerin, Carbomer, Aminomethyl propanol, Fragrance(parfum), Aloe barbadensis leaf extract, May contains FD & C Blue No.1(CI 42090).

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

56 mL NDC: 77969-004-01

56 ml label56 ml label

56 ml label56 ml label56 ml label56 ml label500 mL NDC: 77969-004-02

500 ml label500 ml label

500 ml label500 ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77969-004-012023-01-30C16284748780-1f386c64a-47b7-0266-e053-dadaa90a7c1aHand Sanitizer
77969-004-022023-01-30C16284748780-1f386c64a-47b7-0266-e053-dadaa90a7c1aHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77969-004-01Hand Sanitizer56 mL in 1 BOTTLEGEL563
77969-004-02Hand Sanitizer500 mL in 1 BOTTLEGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77969-004HAND SANITIZER (ALCOHOL) GEL [LEADS (CHINA) BIOTECHNOLOGY CO., LTD.]3Legacy NDC, 2 package rows20200915_aae102ab-a715-3c25-e053-2995a90ac72b.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
77969-00477969-004-01, 77969-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER 9804Q93RCW27EIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
PIGMENT BLUE 14SBE571RQFIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT

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
af42852f-8b0b-5e69-e053-2995a90a757daae102ab-a715-3c25-e053-2995a90ac72b2020-09-14WarningsExact identifier
spl id: af42852f-8b0b-5e69-e053-2995a90a757d
spl set id: aae102ab-a715-3c25-e053-2995a90ac72b

Reported adverse events (FAERS/openFDA)#

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