FDA.reportPublic FDA data

Clean Revolution

Manufacturer
Replenish Bottling LLC
Effective date
2020-07-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:13

Label at a glance#

ProductClean Revolution
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeat use.

Dosage and administration

1. Remove foil seal under cap. 2. For best results , pour into Clean Revolution® Refillable Foaming Bottle. To create foam, product must be dispensed from a foaming pump. Product can also 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. 3. Apply sanitizer to palm. Rub ...

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#

Active Ingredients.... Purpose

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (70% v/v)..... Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeat use.

Warnings

WARNINGS SECTION

For external use.

Flammable . Keep away from heat or flame.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children.

Warnings

OTC - STOP USE SECTION

• Avoid contact with broken skin. Stop use and consult a doctor if irritation or redness appears and lasts.

Warnings

OTC - WHEN USING SECTION

When using, keep out of eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

OTC - ASK DOCTOR SECTION

Avoid contact with broken skin. Stop use and consult a doctor if irritation or redness appears and lasts.

Warnings

OTC - DO NOT USE SECTION

• Do not inhale or ingest.

■ For children under 6, use only under adult supervision .

■ Do not use in children less than 2 years of age.

Warnings

OTC - WHEN USING SECTION

■ 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. For best results , pour into Clean Revolution® Refillable Foaming Bottle. To create foam, product must be dispensed from a foaming pump. Product can also 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.

3. Apply sanitizer to palm. Rub the product over the surfaces of both hands until your hands are dry.

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) , PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer (and) Perflurohexylethyl Alcohol, Glycerin, Coco-glucoside, Bis-Peg-12 Dimethicone, Lavandula Angustifolia (Lavender) Flower Oil, Eucalyptus Globulus Leaf Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785ml NDC 74810-722-03

3785 ml label3785 ml label

443ml NDC 74810-722-04 443 ml label443 ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74810-722-032022-01-28C16284748780-1d6a99b39-75fa-a426-e053-dadaa90af4c2a382d8f9-c7c6-3738-e053-2a95a90a0757
74810-722-042022-01-28C16284748780-1d6a99b39-75fa-a426-e053-dadaa90af4c2a382d8f9-c7c6-3738-e053-2a95a90a0757

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74810-722-03Clean Revolution100 g in 1 BOTTLE, PLASTICLIQUID1002
74810-722-04Clean Revolution100 g in 1 BOTTLE, PUMPLIQUID1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74810-722CLEAN REVOLUTION (HAND SANITIZER) LIQUID [REPLENISH BOTTLING LLC]2Legacy NDC, 2 package rows20200707_a382d8f9-c7c6-3738-e053-2a95a90a0757.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74810-72274810-722-03, 74810-722-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
ALCOHOL3K9958V90MACTIB
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BIS-PEG-12 DIMETHICONE (500 MPA.S)2CNS542YRTIACT
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMERD76Z87928NIACT
EUCALYPTUS OIL2R04ONI662IACT

Source Document#

Source XML · Source PDF

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
a9678fed-bda6-9513-e053-2995a90a25a1a382d8f9-c7c6-3738-e053-2a95a90a07572020-07-01WarningsExact identifier
spl id: a9678fed-bda6-9513-e053-2995a90a25a1
spl set id: a382d8f9-c7c6-3738-e053-2a95a90a0757

Reported adverse events (FAERS/openFDA)#

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