FDA.reportPublic FDA data

Advanced Alcohol Foaming Hand Sanitizer

Manufacturer
Betco Corporation, Ltd.
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:53:42

Label at a glance#

ProductAdvanced Alcohol Foaming Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Uses Use 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

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

Warnings

WARNINGS SECTION

Warnings

  • For external use only. Do not ingest.
  • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
  • Avoid contact with eyes. In case of eye contact, flush with large quantities of water, seek medical attention if irritation persists.
  • If skin irritation develops, discontinue use. If irritation persists for more than 72 hours, seek medical attention.
  • 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-10 Dimethicone, PEG-10 Acrylate/Perfluorohexylethyl Acrylate

Copolymer, Perfluorohexylethyl Alcohol, Propylene Glycol, Fragrance, D&C

Green #5.

Purpose

OTC - PURPOSE SECTION

Purpose

Antiseptic

Advanced Alcohol Foaming Hand Sanitizer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Advanced Alcohol Foaming Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55 gallon55 gallon53535757030329290404

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-800-032024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-042024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-052024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-292024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-532024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-552024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-572024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-882024-11-20C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-032023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-042023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-052023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-292023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-532023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-552023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-572023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer
65601-800-882023-01-30C16284748780-1f386c649-b2df-0266-e053-dadaa90a7c1aAdvanced Alcohol Foaming Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-80065601-800-04, 65601-800-53, 65601-800-57, 65601-800-29, 65601-800-03, 65601-800-05, 65601-800-88, 65601-800-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYCITRONELLAL8SQ0VA4YURIACT
TETRAHYDROLINALOOLUM4XS5M134IACT
ISOPROPYLPHENYLBUTANALZ92022479YIACT
EBANOL28N247O58BIACT
ALOE VERA LEAFZY81Z83H0XIACT
CYCLOMETHICONE 4CZ227117JEIACT
BIS-PEG-12 DIMETHICONE (70 MPA.S)2JDK5W22H4IACT
2-SEC-BUTYL CYCLOHEXANONE5WA6R1KL5JIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
D&C GREEN NO. 58J6RDU8L9XIACT
TETRAHYDROLINALYL ACETATE2NDV3959AXIACT
ALCOHOL3K9958V90MACTIB
HEXYL ACETATE7U7KU3MWT0IACT

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
275b7478-7c34-f593-e063-6394a90a47aca1b0c984-194a-64b8-e053-2a95a90a22b32024-11-20WarningsExact identifier
spl set id: a1b0c984-194a-64b8-e053-2a95a90a22b3

Reported adverse events (FAERS/openFDA)#

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