FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Atara Holdings Inc
Effective date
2016-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:15

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Ethyl Alcohol 62%

OTC - PURPOSE SECTION

Purpose
Antiseptic

WARNINGS SECTION

Warnings

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Pump as needed into your palms to cover hands. Rub hands together briskly unitl dry. Children under 6 years old should be supervised when using this product.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, D&C Red No.33, FD&C Blue No.1.

INDICATIONS & USAGE SECTION

Uses

To help reduce bacteria on the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71154-001-012023-01-30C16284748780-1f386c649-e962-0266-e053-dadaa90a7c1a44689ee0-5221-0689-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71154-001-01Hand Sanitizer29 mL in 1 BOTTLEGEL291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71154-001HAND SANITIZER (ETHYL ALCOHOL) GEL [ATARA HOLDINGS INC]1Legacy NDC, 1 package rows20161225_44689ee0-5221-0689-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71154-00171154-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
LACTOSEJ2B2A4N98GIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SUCROSEC151H8M554IACT
STARCH, CORNO8232NY3SJIACT
ULTRAMARINE BLUEI39WR998BIIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYPROMELLOSES3NXW29V3WOIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
44689ee0-5222-0689-e054-00144ff88e8844689ee0-5221-0689-e054-00144ff88e882016-12-24WarningsExact identifier
spl id: 44689ee0-5222-0689-e054-00144ff88e88
spl set id: 44689ee0-5221-0689-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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