FDA.reportPublic FDA data

RawHarvest Hand Sanitizer Sensitive Skin

Manufacturer
AMERICAN ORGANIC FOOD COMPANY LLC
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:13

Label at a glance#

ProductRawHarvest Hand Sanitizer Sensitive Skin
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Dispense 1 to 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands. Continue rubbing until dry. Use frequently to avoid spreading germs.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.11% - 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Warnings

WARNINGS SECTION

Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
Discontinue use if skin irritation or redness develops.
No for use on sensitive areas of the body or burns.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Dispense 1 to 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands.
Continue rubbing until dry. Use frequently to avoid spreading germs.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water 99.83%, Carbamide to 0.04%

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79374-140-012022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-022022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-032022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-042022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-052022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-062022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-072022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-082022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-092022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-102022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-112022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-122022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3
79374-140-132022-01-28C16284748780-1d6a99b39-c4bd-a426-e053-dadaa90af4c248018a4b-5ee4-4d3b-a992-9d1eff1f66c3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79374-140-01RawHarvest Hand Sanitizer Sensitive Skin20 mL in 1 BOTTLE, SPRAYLIQUID201
79374-140-02RawHarvest Hand Sanitizer Sensitive Skin50 mL in 1 BOTTLE, PUMPLIQUID501
79374-140-03RawHarvest Hand Sanitizer Sensitive Skin60 mL in 1 BOTTLE, SPRAYLIQUID601
79374-140-04RawHarvest Hand Sanitizer Sensitive Skin90 mL in 1 BOTTLE, SPRAYLIQUID901
79374-140-05RawHarvest Hand Sanitizer Sensitive Skin120 mL in 1 BOTTLE, SPRAYLIQUID1201
79374-140-06RawHarvest Hand Sanitizer Sensitive Skin240 mL in 1 BOTTLE, SPRAYLIQUID2401
79374-140-07RawHarvest Hand Sanitizer Sensitive Skin480 mL in 1 BOTTLE, SPRAYLIQUID4801
79374-140-08RawHarvest Hand Sanitizer Sensitive Skin750 mL in 1 BOTTLE, SPRAYLIQUID7501
79374-140-09RawHarvest Hand Sanitizer Sensitive Skin950 mL in 1 BOTTLE, SPRAYLIQUID9501
79374-140-10RawHarvest Hand Sanitizer Sensitive Skin1893 mL in 1 JUGLIQUID18931
79374-140-11RawHarvest Hand Sanitizer Sensitive Skin3785 mL in 1 JUGLIQUID37851
79374-140-12RawHarvest Hand Sanitizer Sensitive Skin208000 mL in 1 DRUMLIQUID2080001
79374-140-13RawHarvest Hand Sanitizer Sensitive Skin1045000 mL in 1 CONTAINERLIQUID10450001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79374-140RAWHARVEST HAND SANITIZER SENSITIVE SKIN (BENZALKONIUM CHLORIDE) LIQUID [AMERICAN ORGANIC FOOD COMPANY LLC]1Legacy NDC, 13 package rows20200707_48018a4b-5ee4-4d3b-a992-9d1eff1f66c3.zip

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
79374-14079374-140-01, 79374-140-02, 79374-140-03, 79374-140-04, 79374-140-05, 79374-140-06, 79374-140-07, 79374-140-08, 79374-140-09, 79374-140-10, 79374-140-11, 79374-140-12, 79374-140-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
UREA8W8T17847WIACT
WATER059QF0KO0RIACT

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
6ce7b31f-854d-4d3f-acef-b60707d427f848018a4b-5ee4-4d3b-a992-9d1eff1f66c32020-07-02WarningsExact identifier
spl id: 6ce7b31f-854d-4d3f-acef-b60707d427f8
spl set id: 48018a4b-5ee4-4d3b-a992-9d1eff1f66c3

Reported adverse events (FAERS/openFDA)#

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