FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Brands International
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl alcohol 62%.

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings

Flammable, keep away from fire or flame.For external use only.

When using this product Avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor If redness or irritation develop and persist for more than 72 hours.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Spread on both hands, rub in, let dry.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water, Isopropyl Myristate, Aminomethyl Propanol.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN3
581660ethanol 0.62 ML/ML Topical GelSCD3
581660ethanol 62 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-501-012025-01-30C16284748780-12cef2736-6b94-d83d-e063-dadaa90ab31fSpa Soap Hand Sanitizer: Moisturizing
50157-501-022025-01-30C16284748780-12cef2736-6b94-d83d-e063-dadaa90ab31fSpa Soap Hand Sanitizer: Moisturizing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-501-01Hand Sanitizer600 mL in 1 BOTTLEGEL6003
50157-501-02Hand Sanitizer946 mL in 1 BOTTLEGEL9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-501HAND SANITIZER GEL [BRANDS INTERNATIONAL]3Legacy NDC, 2 package rows20221213_9c12f0b8-e1b6-47d0-9eaf-283b8c35ec21.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-50150157-501-01, 50157-501-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOEV5VD430YW9IACT
TROLAMINE9O3K93S3TKIACT
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
efa6911e-270d-68ed-e053-2a95a90ab9ea9c12f0b8-e1b6-47d0-9eaf-283b8c35ec212022-12-12WarningsExact identifier
spl id: efa6911e-270d-68ed-e053-2a95a90ab9ea
spl set id: 9c12f0b8-e1b6-47d0-9eaf-283b8c35ec21

Reported adverse events (FAERS/openFDA)#

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