FDA.reportPublic FDA data

BENZETHONIUM CHLORIDE

Manufacturer
Replenish Bottling LLC
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:41

Label at a glance#

ProductClean Revolution Anti-Bacterial Hand Refill Supply Container - Anti-Bacterial - ELIMINATES 99.9% Germs - Ready To Use...
Active ingredientBENZETHONIUM CHLORIDE
Label structure7 sections

Indications and uses

For handwashing to decrease bacteria on the skin.

Dosage and administration

1. Remove foil seal under cap. 2. Apply to hands and wet as needed. Lather vigorously for at least 15 seconds. 3. Wash skin, rinse thoroughly and dry. 4. For best results, pour into Clean Revolution® Refillable Bottle. Product can be dispensed in a liquid consistency using a standard pump or spray bottle. Never mix this product with other household ingredients or pour into a bottle that previously contained other ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For External Use Only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

When using, 

OTC - WHEN USING SECTION

  • keep out of eyes. In case of contact, rinse eyes thoroughly with water. 
  • Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.
  • Do not inhale or ingest.
  • If swallowed, get medical help or contact a Poison Control Center right away.
  • Only use with dispensers and containers that have been cleaned, rinsed and are empty.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Remove foil seal under cap.
2. Apply to hands and wet as needed. Lather vigorously for at least 15 seconds.
3. Wash skin, rinse thoroughly and dry.
4. For best results, pour into Clean Revolution® Refillable Bottle. Product can be dispensed in a liquid consistency using a standard pump or spray bottle. Never mix this product with other household ingredients or pour into a bottle that previously contained other chemicals.

Other Information

SPL UNCLASSIFIED SECTION

Store at 40-95°F (4-35°C)
Avoid freezing and excessive heat above 104°F (40°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Cetrimonium Chloride, Citric Acid, Cocamide MEA, Cocamidopropylamine Oxide, Fragrance, Glycerin, PEG-200 Glyceryl Stearate, Red 4, Salicylic Acid, Sorbic Acid, Tetrasodium EDTA, Water, Yellow 5, (may contain Sodium Hydroxide) 

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039026benzethonium chloride 0.13 % Medicated Liquid SoapPSN2
1039026benzethonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1039026benzethonium chloride 0.13 % Medicated Liquid SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74810-728-00Clean Revolution Anti-Bacterial Hand Refill Supply Container - Anti-Bacterial - ELIMINATES 99.9% Germs - Ready To Use - Fresh Orange3785 mL in 1 BOTTLELIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74810-728CLEAN REVOLUTION ANTI-BACTERIAL HAND REFILL SUPPLY CONTAINER - ANTI-BACTERIAL - ELIMINATES 99.9% GERMS - READY TO USE - FRESH ORANGE (BENZETHONIUM CHLORIDE) LIQUID [REPLENISH BOTTLING LLC]2Current NDC, 1 package rows20231227_2838b366-0879-411f-8e49-1a85e4151daf.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
74810-72874810-728-00

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
BENZYL ALCOHOLLKG8494WBHIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO MONOETHANOLAMIDEC80684146DIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
GLYCERINPDC6A3C0OXIACT
PEG-200 GLYCERYL STEARATEZ8ROG2A0LZIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SALICYLIC ACIDO414PZ4LPZIACT
SORBIC ACIDX045WJ989BIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
Clean Revolution Anti-Bacterial Hand Refill Supply Container - Anti-Bacterial - ELIMINATES 99.9% Germs - Ready To Use - Fresh OrangeBENZETHONIUM CHLORIDEReplenish Bottling LLC2838b366-0879-411f-8e49-1a85e4151daf2023-12-26WarningsExact identifier
ndc (package): 74810-728-00
ndc (product): 74810-728
ndc11 (package): 74810072800
spl id: 0d773c0d-7a2c-d567-e063-6394a90a9c54
spl set id: 2838b366-0879-411f-8e49-1a85e4151daf

Reported adverse events (FAERS/openFDA)#

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