FDA.reportPublic FDA data

hand sanitizer

Manufacturer
Y&R International (Wuhu) Industrial Limited | H&O International Pty Ltd
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:13:42

Label at a glance#

Producthand sanitizer
Active ingredientALCOHOL
Label structure6 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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water and not available.

WARNINGS

WARNINGS SECTION

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

Do not use

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed,
get medicalhelp or contact a Poison Control Center.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Aminomethyl Propanol, Carbomer, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74834-001-012022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-022022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-032022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-042022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-052022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-062022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-072022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-082022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-092022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-102022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-112022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-122022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-132022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-142022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-152022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-162022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-172022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-182022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-192022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-202022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-212022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-222022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-232022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-242022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-252022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-262022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-272022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-282022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-292022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer
74834-001-302022-01-28C16284748780-1d6a99b39-d964-a426-e053-dadaa90af4c274834-001 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74834-001-01hand sanitizer60 mL in 1 BOTTLEGEL603
74834-001-01hand sanitizer100 in 1 CARTONGEL1003
74834-001-02hand sanitizer30 mL in 1 BOTTLEGEL303
74834-001-02hand sanitizer100 in 1 CARTONGEL1003
74834-001-03hand sanitizer50 in 1 CARTONGEL503
74834-001-03hand sanitizer100 mL in 1 BOTTLEGEL1003
74834-001-04hand sanitizer240 mL in 1 BOTTLEGEL2403
74834-001-04hand sanitizer20 in 1 CARTONGEL203
74834-001-05hand sanitizer250 mL in 1 BOTTLEGEL2503
74834-001-05hand sanitizer20 in 1 CARTONGEL203
74834-001-06hand sanitizer300 mL in 1 BOTTLEGEL3003
74834-001-06hand sanitizer20 in 1 CARTONGEL203
74834-001-07hand sanitizer20 in 1 CARTONGEL203
74834-001-07hand sanitizer500 mL in 1 BOTTLEGEL5003
74834-001-08hand sanitizer1000 mL in 1 BOTTLEGEL10003
74834-001-08hand sanitizer12 in 1 CARTONGEL123
74834-001-09hand sanitizer2000 mL in 1 BOTTLEGEL20003
74834-001-09hand sanitizer6 in 1 CARTONGEL63
74834-001-10hand sanitizer4 in 1 CARTONGEL43
74834-001-10hand sanitizer4500 mL in 1 BOTTLEGEL45003
74834-001-11hand sanitizer60 mL in 1 BOTTLEGEL603
74834-001-12hand sanitizer30 mL in 1 BOTTLEGEL303
74834-001-13hand sanitizer100 mL in 1 BOTTLEGEL1003
74834-001-14hand sanitizer240 mL in 1 BOTTLEGEL2403
74834-001-15hand sanitizer250 mL in 1 BOTTLEGEL2503
74834-001-16hand sanitizer300 mL in 1 BOTTLEGEL3003
74834-001-17hand sanitizer500 mL in 1 BOTTLEGEL5003
74834-001-18hand sanitizer1000 mL in 1 BOTTLEGEL10003
74834-001-19hand sanitizer2000 mL in 1 BOTTLEGEL20003
74834-001-20hand sanitizer4500 mL in 1 BOTTLEGEL45003
74834-001-21hand sanitizer10 mL in 1 BOTTLEGEL103
74834-001-22hand sanitizer59 mL in 1 BOTTLEGEL593
74834-001-23hand sanitizer150 mL in 1 BOTTLEGEL1503
74834-001-24hand sanitizer200 mL in 1 BOTTLEGEL2003
74834-001-25hand sanitizer236 mL in 1 BOTTLEGEL2363
74834-001-26hand sanitizer237 mL in 1 BOTTLEGEL2373
74834-001-27hand sanitizer499 mL in 1 BOTTLEGEL4993
74834-001-28hand sanitizer946 mL in 1 BOTTLEGEL9463
74834-001-29hand sanitizer1005 mL in 1 BOTTLEGEL10053
74834-001-30hand sanitizer5000 mL in 1 BOTTLEGEL50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74834-001HAND SANITIZER (ETHYL ALCOHOL) GEL [Y&R INTERNATIONAL (WUHU) INDUSTRIAL LIMITED]3Legacy NDC, 40 package rows20200520_a30d30fb-ca43-01ae-e053-2a95a90a0b2c.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
74834-00174834-001-01, 74834-001-02, 74834-001-03, 74834-001-04, 74834-001-05, 74834-001-06, 74834-001-07, 74834-001-08, 74834-001-09, 74834-001-10, 74834-001-11, 74834-001-12, 74834-001-13, 74834-001-14, 74834-001-15, 74834-001-16, 74834-001-17, 74834-001-18, 74834-001-19, 74834-001-20, 74834-001-21, 74834-001-22, 74834-001-23, 74834-001-24, 74834-001-25, 74834-001-26, 74834-001-27, 74834-001-28, 74834-001-29, 74834-001-30

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
GLYCERINPDC6A3C0OXIACT
TOCOPHERYL RETINOATE0WN694NBMMIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
CARBOMER 934Z135WT9208IACT
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
a6096dd5-4a14-291d-e053-2995a90a9c0fa30d30fb-ca43-01ae-e053-2a95a90a0b2c2020-05-19WarningsExact identifier
spl id: a6096dd5-4a14-291d-e053-2995a90a9c0f
spl set id: a30d30fb-ca43-01ae-e053-2a95a90a0b2c

Reported adverse events (FAERS/openFDA)#

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