FDA.reportPublic FDA data

Fundamentals

Manufacturer
Clean Beauty Concepts
Effective date
2020-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:47

Label at a glance#

ProductFundamentals
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

• Wet hands, apply palmful to hands, scrub thoroughly, rinse thoroughly Supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

Store between 15-30°C (59-86°F) . • Avoid freezing and excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

The hand soap is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

Benzalkonium chloride

Water(aqua)

Sodium alpha olefin sulfonate

Cocamide DIPA

Cocamidopropyl betaine

Glycerin

Polyquaternium-7

Phenoxyethanol

Aloe barbadensis (aloe vera) leaf juice

Sodium benzoate

Citric acid

Sodium chloride

Tetrasodium EDTA

Fragrance (parfum)

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% v/v. Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin

Recommended for repeat use

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if

irritation or redness develop

Condition persists more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands, apply palmful to hands, scrub thoroughly, rinse thoroughly

  • Supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30°C (59-86°F) .
    • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(aqua)

Sodium alpha olefin sulfonate

Cocamide DIPA

Cocamidopropyl betaine

Glycerin

Polyquaternium-7

Phenoxyethanol

Aloe barbadensis (aloe vera) leaf juice

Sodium benzoate

Citric acid

Sodium chloride

Tetrasodium EDTA

Fragrance (parfum)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL NDC: 76665-016-08

Lemon 8 ozLemon 8 oz

473 mL NDC: 76665-016-16

16oz label16oz label

60 mL NDC: 76665-016-02

2oz label2oz label 3785mL NDC: 76665-016-01

1 Gallon1 Gallon

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76665-016-012022-01-28C16284748780-1d6a99b39-cb5d-a426-e053-dadaa90af4c2b0e32207-902e-ec9e-e053-2995a90afbef
76665-016-022022-01-28C16284748780-1d6a99b39-cb5d-a426-e053-dadaa90af4c2b0e32207-902e-ec9e-e053-2995a90afbef
76665-016-082022-01-28C16284748780-1d6a99b39-cb5d-a426-e053-dadaa90af4c2b0e32207-902e-ec9e-e053-2995a90afbef
76665-016-162022-01-28C16284748780-1d6a99b39-cb5d-a426-e053-dadaa90af4c2b0e32207-902e-ec9e-e053-2995a90afbef

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76665-016-01Fundamentals3785 mL in 1 BOTTLE, DISPENSINGSOAP37853
76665-016-02Fundamentals60 mL in 1 BOTTLE, DISPENSINGSOAP603
76665-016-08Fundamentals236 mL in 1 BOTTLE, DISPENSINGSOAP2363
76665-016-16Fundamentals473 mL in 1 BOTTLE, DISPENSINGSOAP4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76665-016FUNDAMENTALS (BENZALKONIUM CHLORIDE) SOAP [CLEAN BEAUTY CONCEPTS]3Legacy NDC, 4 package rows20201017_b0e32207-902e-ec9e-e053-2995a90afbef.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76665-01676665-016-08, 76665-016-16, 76665-016-02, 76665-016-01

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
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM BENZOATEOJ245FE5EUIACT
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATEQI9A6U005WIACT
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM C12 OLEFIN SULFONATEK7QRZ05DE3IACT

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
b1d15050-1067-4b23-e053-2995a90aeebbb0e32207-902e-ec9e-e053-2995a90afbef2020-10-16WarningsExact identifier
spl id: b1d15050-1067-4b23-e053-2995a90aeebb
spl set id: b0e32207-902e-ec9e-e053-2995a90afbef

Reported adverse events (FAERS/openFDA)#

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