FDA.reportPublic FDA data

BENZETHONIUM CHLORIDE

Manufacturer
FRUIT OF THE EARTH, INC.
Effective date
2021-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:30:13

Label at a glance#

ProductFruit of the Earth Grapefruit Scented Antibacterial Hand with Canadian Willowherb
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

wash hands and rinse

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

helps reduce bacteria on hands

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on infants under 6 months of age

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact, flush with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs.

Keep out of reach of chlidren

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

except under adult supervision. If swallowed, get medical help or contract a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

wash hands and rinse

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Decyl Glucoside, Glycerin, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Fragrance, Phenoxyethanol, Citric Acid, Epilobium Angustifolium Flower/Leaf/Stem Extract, Tetrasodium EDTA, Alcohol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

47295E47295E

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
62217-08662217-086-87

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 4X3W0AM1JLXIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALCOHOL3K9958V90MIACT

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
24c784b5-a8b2-d355-e063-6394a90a337ecf719aac-d846-45e5-e053-2a95a90aa23e2024-10-18WarningsExact identifier
spl set id: cf719aac-d846-45e5-e053-2a95a90aa23e

Reported adverse events (FAERS/openFDA)#

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