FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
HUB PEN COMPANY, INC.
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:58

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Hand sanitizer to help bacteria on skin.

Dosage and administration

Wet hands throughly with product, briskly rub together until dry. Always supervid=se children in the use of this product. Children under age of 6 months: asl a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive IngredientEthyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic PurposePurpose

Uses

DOSAGE & ADMINISTRATION SECTION

Hand sanitizer to help bacteria on skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat and flame.

For external use only.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. When using this productWhen using this product

In case of cotact with eyes, flush througly with water.

Avoid contact with broken skin.

do not inhale or ingest.

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation and redness develops and persists for more than 72 hours.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer, Glycerine, Thrietanolamine, Water.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

Wet hands throughly with product, briskly rub together until dry.

Always supervid=se children in the use of this product.

Children under age of 6 months: asl a doctor.

PDP panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display panelPrincipal display panelHand Snitizer

5ml 017 fl oz

NDC 77988-003-01

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77988-00377988-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
eb689f47-ef38-18c0-e053-2a95a90aad87ab108618-5059-d27c-e053-2995a90a9a762022-10-19WarningsExact identifier
spl set id: ab108618-5059-d27c-e053-2995a90a9a76

Reported adverse events (FAERS/openFDA)#

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