FDA.reportPublic FDA data

Sanell Hand Sanitizer

Manufacturer
OraLabs
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:49

Label at a glance#

ProductSanell Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For handwashing to decrease bacteria on the skin.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 63.00%

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only: Hands. Flammable. Keep away from fire or flame. Do not use in the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor: if irritation and redness develop and persists for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance, Polysorbate 20, Propanediol, Water.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sanell 10 ml Hand Sanitizer Template
Sanell 10 ml Hand Sanitizer Template

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798385alcohol 63 % Topical SprayPSN3
1798385ethanol 0.63 ML/ML Topical SpraySCD3
1798385ethanol 63 % Topical SpraySY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-174-022025-04-28C16284748780-12cef2736-a1f9-d83d-e063-dadaa90ab31fDrug Facts
63645-174-022025-01-30C16284748780-12cef2736-a1f9-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-174-02Sanell Hand Sanitizer10 mL in 1 BOTTLESPRAY103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-174SANELL HAND SANITIZER (ALCOHOL) SPRAY [ORALABS]3Current NDC, Legacy NDC, 1 package rows20250429_0a6cc2a8-f568-45ae-8d82-a70103c774c7.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63645-17463645-174-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
Sanell Hand SanitizerALCOHOLOraLabs0a6cc2a8-f568-45ae-8d82-a70103c774c72025-04-28WarningsExact identifier
ndc (package): 63645-174-02
ndc (product): 63645-174
ndc11 (package): 63645017402
spl id: 33dd4273-5402-5be0-e063-6394a90a41c1
spl set id: 0a6cc2a8-f568-45ae-8d82-a70103c774c7

Reported adverse events (FAERS/openFDA)#

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