Hand Sanitizer

Manufacturer
SOFi Paper Products LLC
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:18

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable, Keep away from fire or flame.

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using.

Other Information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Triethanolamine, Carbopol, Tween 20, Glycerin, Aloe

Package Labeling:78227-000-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:78227-000-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:78227-000-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78227-000-012022-01-28C16284748780-1d6a99b39-dc45-a426-e053-dadaa90af4c2Hand Sanitizer
78227-000-022022-01-28C16284748780-1d6a99b39-dc45-a426-e053-dadaa90af4c2Hand Sanitizer
78227-000-032022-01-28C16284748780-1d6a99b39-dc45-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78227-000-01Hand Sanitizer236 mL in 1 BOTTLEGEL2362
78227-000-02Hand Sanitizer250 mL in 1 BOTTLEGEL2502
78227-000-03Hand Sanitizer3785 mL in 1 BOTTLEGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78227-000HAND SANITIZER (ALCOHOL) GEL [SOFI PAPER PRODUCTS LLC]2Legacy NDC, 3 package rows20200612_99c30aa4-4880-4ef7-9602-f84d04244d93.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78227-00078227-000-01, 78227-000-02, 78227-000-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
a7d08f4a-f735-3500-e053-2995a90a856c99c30aa4-4880-4ef7-9602-f84d04244d932020-06-11WarningsExact identifier
spl id: a7d08f4a-f735-3500-e053-2995a90a856c
spl set id: 99c30aa4-4880-4ef7-9602-f84d04244d93

Reported adverse events (FAERS/openFDA)#

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