FDA.reportPublic FDA data

Amazon Commercial Alcohol Free Foam Hand Sanitizer

Manufacturer
Amazon.com Services | Betco corporation, Ltd.
Effective date
2021-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:56:07

Label at a glance#

ProductAmazon Commercial Alcohol Free Foam Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

Benzalkonium Chloride 0.13%

INDICATIONS & USAGE SECTION

Uses

  • Use in a variety of public facilities.
  • Use this product when soap and water are not available.

WARNINGS SECTION

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • Children under the age of 6 should be supervised by an adult when using this product.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

Directions

  • ​Read the entire label before using this product.
  • ​Dispense product onto dry hands. Rub hands together until hands are dry.
  • Use as needed between hand washes to reduce bacteria on the skin.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, DMDM Hydantoin, PEG-3 Cocamide, Fragrance, Iodoproynyl Btylcarbamate, D&C Green #5.

OTC - QUESTIONS SECTION

Questions or Comments?Phone: (800) 777-9343

MDS information:​(800) 891-4965

OTC - PURPOSE SECTION

Purpose

Antiseptic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Amazon Commercial Alcohol Free Foam Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label change RTK ingredientsLabel change RTK ingredients

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72288-752-042024-11-20C16284748780-1f386c649-f513-0266-e053-dadaa90a7c1aAmmazon Commercial Alcohol Free Foam Hand Sanitizer
72288-752-042023-01-30C16284748780-1f386c649-f513-0266-e053-dadaa90a7c1aAmmazon Commercial Alcohol Free Foam Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72288-75272288-752-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
GERANIOLL837108USYIACT
SODIUM PIDOLATE1V74VH163TIACT
GRAPEFRUIT OILYR377U58W9IACT
PEG/PPG-15/15 ALLYL ETHER ACETATE8RP39FN7AJIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18)9U1Q4T4ZYSIACT
ORANGE OILAKN3KSD11BIACT
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT
DIOXANEJ8A3S10O7SIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
CYCLOMETHICONE 4CZ227117JEIACT
HEXYL SALICYLATE8F78EY72YLIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
ACETALDEHYDEGO1N1ZPR3BIACT
LIME OILUZH29XGA8GIACT
LEMON OILI9GRO824LLIACT
MAGNESIUM NITRATE77CBG3UN78IACT
HEXAMETHYLINDANOPYRAN14170060ATIACT
MYRCENE3M39CZS25BIACT
DIHYDROMYRCENOL46L1B02ND9IACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
WATER059QF0KO0RIACT
D&C GREEN NO. 58J6RDU8L9XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
275b285f-fff5-963f-e063-6294a90af3ebabbf69f4-db3d-1119-e053-2a95a90ab5d12024-11-20WarningsExact identifier
spl set id: abbf69f4-db3d-1119-e053-2a95a90ab5d1

Reported adverse events (FAERS/openFDA)#

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