FDA.reportPublic FDA data

Advanced Alcohol Gel Sanitizer

Manufacturer
Betco Corporation, Ltd
Effective date
2019-08-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:00:00

Label at a glance#

ProductAdvanced Alcohol Gel Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Uses • Hand sanitizer to reduce microorganisms on the skin. • Use this product when soap and water are not available.

Dosage and administration

Directions • Read the entire label before using this product. • Place enough product on your palm to thoroughly cover your hands. • Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70%

Uses

INDICATIONS & USAGE SECTION

Uses

• Hand sanitizer to reduce microorganisms on the skin.

• Use this product when soap and water are not available.

Purpose

OTC - PURPOSE SECTION

Purpose

Antiseptic

Warnings

WARNINGS SECTION

Warnings

• For external use only.

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• FLAMMABLE. This product contains ethyl alcohol. Keep away from

sources of ignition.

• Discontinue use if irritation or redness develops.

• If irritation persists for more than 72 hours, consult a physician.

• KEEP OUT OF REACH OF CHILDREN.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

• Read the entire label before using this product.

• Place enough product on your palm to thoroughly cover your hands.

• Rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, PEG/PPG-8/3 Laurate, Gycerin, Carbomer, Tetrahydroxypropylethylendiamine, Fragrance.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AdvancedAlcoholGelSanitizerAdvancedAlcoholGelSanitizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-796-192025-01-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-292025-01-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-572025-01-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-192024-10-01C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-292024-10-01C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-572024-10-01C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-192024-07-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-292024-07-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-572024-07-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-192024-01-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-292024-01-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer
65601-796-572024-01-30C16284748780-11030e365-2f09-111a-e063-dadaa90a10e2Advanced Alcohol Gel Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65601-796-19Advanced Alcohol Gel Sanitizer900 mL in 1 BAGGEL9003
65601-796-29Advanced Alcohol Gel Sanitizer1000 mL in 1 BAGGEL10003
65601-796-57Advanced Alcohol Gel Sanitizer550 mL in 1 BOTTLE, PUMPGEL5503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65601-796ADVANCED ALCOHOL GEL SANITIZER (ALCOHOL) GEL [BETCO CORPORATION, LTD]3Legacy NDC, 3 package rows20190806_8dbdd28e-2bb5-a4be-e053-2a95a90a5883.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-79665601-796-19, 65601-796-29, 65601-796-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DIMETHICONE PEG-8 LAURATE72MF9C2A18IACT
GLYCERINPDC6A3C0OXIACT
EDETOLQ4R969U9FRIACT

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
8f62fa63-2270-ecf6-e053-2995a90ac7d88dbdd28e-2bb5-a4be-e053-2a95a90a58832019-08-01WarningsExact identifier
spl id: 8f62fa63-2270-ecf6-e053-2995a90ac7d8
spl set id: 8dbdd28e-2bb5-a4be-e053-2a95a90a5883

Reported adverse events (FAERS/openFDA)#

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