FDA.reportPublic FDA data

U Alcohol

Manufacturer
Honest Co., Ltd.
Effective date
2020-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:39

Label at a glance#

ProductU Alcohol
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin

Dosage and administration

• Place enough product in your palm to cover hands. Rub hands together until dry. • Children under 6 years of age should be supervised when using the product

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ALCOHOL 70% v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Extract, Glycerin, Carbomer, Butylene Glycol, Citrus Limon Fruit Extract, Triethanolamine, 1,2-Hexanediol

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

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

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

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product in your palm to cover hands. Rub hands together until dry.

• Children under 6 years of age should be supervised when using the product

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133862601240325GTIN-13: 3862601240325
EAN-13: 3862601240325
GTIN storage (14 digits): 03862601240325		500 bottle.jpg
BarcodeEAN-138809601240325GTIN-13: 8809601240325
EAN-13: 8809601240325
GTIN storage (14 digits): 08809601240325		500 bottle.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76904-100-012024-01-30C16284748780-11030e365-4291-111a-e063-dadaa90a10e236a5c0da-3806-4ecf-97cd-93566c91d0dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76904-100-01U Alcohol500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76904-100U ALCOHOL (ALCOHOL) GEL [HONEST CO., LTD.]1Legacy NDC, 1 package rows20200527_36a5c0da-3806-4ecf-97cd-93566c91d0dd.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76904-10076904-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GlycerinPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
Butylene Glycol3XUS85K0RAIACT
LEMON24RS0A988OIACT
TROLAMINE9O3K93S3TKIACT
1,2-HexanediolTR046Y3K1GIACT

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
989f1c5c-52da-4a4c-84dc-3d97e66178fe36a5c0da-3806-4ecf-97cd-93566c91d0dd2020-05-27WarningsExact identifier
spl id: 989f1c5c-52da-4a4c-84dc-3d97e66178fe
spl set id: 36a5c0da-3806-4ecf-97cd-93566c91d0dd

Reported adverse events (FAERS/openFDA)#

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