Hand Sanitizer

Manufacturer
Magus Brands, LLC | Signature Filling Company LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:39

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

■ Hand sanitizer to help reduce germs on the skin that could cause disease

Dosage and administration

■ Spray product in hands and wet thoroughly. ■ Rub hands together briskly until dry. ■ Children under 6 years of age should be supervised

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Hand sanitizer to help reduce germs on the skin that could cause disease

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredientPurpose
Ethyl Alcohol 70%Antimicrobial

Uses

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help reduce germs on the skin that could cause disease

Warnings

WARNINGS SECTION

For external use only.

OTHER SAFETY INFORMATION

■ Flammable. Keep away from fire or flame.

■ Contents under pressure. Do not puncture/incinerate.

■ Do not store at temperatures above 120°F.

OTC - WHEN USING SECTION

When using this product

■ Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes with water.

■ Avoid contact with broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irrititation develops, or if condition persists 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Spray product in hands and wet thoroughly.

■ Rub hands together briskly until dry.

■ Children under 6 years of age should be supervised

Inactive ingredients

INACTIVE INGREDIENT SECTION

Fragrance, Water

Questions or comments?

OTC - QUESTIONS SECTION

949-237-2869

RECENT MAJOR CHANGES SECTION

No change

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NET WT 4 OZ (113G) NDC: 80478-1000-1

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80478-1000-12025-01-24C16284748780-11030e365-443e-111a-e063-dadaa90a10e2Ethasol Hand Sanitizer Ethyl Alcohol 70%
80478-1000-12024-01-30C16284748780-11030e365-443e-111a-e063-dadaa90a10e2Ethasol Hand Sanitizer Ethyl Alcohol 70%

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
80478-100080478-1000-1

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
2c666815-4c15-a9cf-e063-6394a90af8d0b32bb900-2d54-0011-e053-2a95a90a4f792025-01-23WarningsExact identifier
spl set id: b32bb900-2d54-0011-e053-2a95a90a4f79

Reported adverse events (FAERS/openFDA)#

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