FDA.reportPublic FDA data

Hand Sanitizer-Gel

Manufacturer
Zotos International Inc
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:18

Label at a glance#

ProductHand Sanitizer-Gel
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and rub into skin until dry. Children under 6 years of age should be supervised by an adult when using this product.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame

OTC - WHEN USING SECTION

When using this product keep avoid contact with face, eyes, and broken skin. if eye contact occurs, flush thoroughly with water and seek medical advice.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Wet hands thoroughly with product and rub into skin until dry.

Children under 6 years of age should be supervised by an adult when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water, Eau)• Propylene Glycol• Glycerin• Carbomer • Aminomethyl Propane! • lsopropyl Myrlstate • T-Butyl Alcohol

Questions

OTHER SAFETY INFORMATION

? 1-877-777-3277

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gel AWGel AWsanit 7.5sanit 7.5Sanitizer 16Sanitizer 16Sanit 443Sanit 443Sanitizer 800Sanitizer 800

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50663-003-012022-01-28C16284748780-1d6a99b39-f14f-a426-e053-dadaa90af4c2a44cf10f-c72d-811d-e053-2a95a90a0d6f
50663-003-022022-01-28C16284748780-1d6a99b39-f14f-a426-e053-dadaa90af4c2a44cf10f-c72d-811d-e053-2a95a90a0d6f
50663-003-032022-01-28C16284748780-1d6a99b39-f14f-a426-e053-dadaa90af4c2a44cf10f-c72d-811d-e053-2a95a90a0d6f
50663-003-042022-01-28C16284748780-1d6a99b39-f14f-a426-e053-dadaa90af4c2a44cf10f-c72d-811d-e053-2a95a90a0d6f
50663-003-052022-01-28C16284748780-1d6a99b39-f14f-a426-e053-dadaa90af4c2a44cf10f-c72d-811d-e053-2a95a90a0d6f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50663-003-01Hand Sanitizer-Gel118 mL in 1 BOTTLEGEL1181
50663-003-02Hand Sanitizer-Gel221 mL in 1 BOTTLE, PUMPGEL2211
50663-003-03Hand Sanitizer-Gel443 mL in 1 BOTTLE, PUMPGEL4431
50663-003-04Hand Sanitizer-Gel473 mL in 1 CELLO PACKGEL4731
50663-003-05Hand Sanitizer-Gel800 mL in 1 CELLO PACKGEL8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50663-003HAND SANITIZER-GEL (DIAL PROFESSIONAL GEL HAND SANITIZER) GEL [ZOTOS INTERNATIONAL INC]1Legacy NDC, 5 package rows20200502_a44cf10f-c72d-811d-e053-2a95a90a0d6f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50663-00350663-003-01, 50663-003-02, 50663-003-03, 50663-003-04, 50663-003-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
Propylene Glycol6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT

Source Document#

Source XML · Source PDF

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
a44cec41-bb92-811f-e053-2a95a90a1885a44cf10f-c72d-811d-e053-2a95a90a0d6f2020-04-27WarningsExact identifier
spl id: a44cec41-bb92-811f-e053-2a95a90a1885
spl set id: a44cf10f-c72d-811d-e053-2a95a90a0d6f

Reported adverse events (FAERS/openFDA)#

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