FDA.reportPublic FDA data

Clean and Pure Hand Sanitizer Gel

Manufacturer
EVESEL CO., LTD.
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:36:43

Label at a glance#

ProductClean and Pure Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Carbomer, Triethanolamine, perfume, Polysorbate 60, DL-Panthenol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol 70%

Clean & Pure

Hand Sanitizer Gel

Kills more than 99.9% of Germs

Alcohol Antiseptic 70%

Topical Solution

Effective Inhibition

non-sterile solution

Improved formula

500 mL / 16 fl.oz.

100ml100ml

300ml300ml

120ml120ml

60ml60ml

clean and pure labelclean and pure label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78146-701-102023-01-30C16284748780-1f386c649-d850-0266-e053-dadaa90a7c1aClean & Pure Hand Sanitizer Gel
78146-701-112023-01-30C16284748780-1f386c649-d850-0266-e053-dadaa90a7c1aClean & Pure Hand Sanitizer Gel
78146-701-122023-01-30C16284748780-1f386c649-d850-0266-e053-dadaa90a7c1aClean & Pure Hand Sanitizer Gel
78146-701-302023-01-30C16284748780-1f386c649-d850-0266-e053-dadaa90a7c1aClean & Pure Hand Sanitizer Gel
78146-701-502023-01-30C16284748780-1f386c649-d850-0266-e053-dadaa90a7c1aClean & Pure Hand Sanitizer Gel
78146-701-602023-01-30C16284748780-1f386c649-d850-0266-e053-dadaa90a7c1aClean & Pure Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78146-701-10Clean and Pure Hand Sanitizer Gel3785 mL in 1 BOTTLEGEL37855
78146-701-11Clean and Pure Hand Sanitizer Gel1000 mL in 1 BOTTLEGEL10005
78146-701-12Clean and Pure Hand Sanitizer Gel120 mL in 1 BOTTLEGEL1205
78146-701-30Clean and Pure Hand Sanitizer Gel300 mL in 1 BOTTLEGEL3005
78146-701-50Clean and Pure Hand Sanitizer Gel500 mL in 1 BOTTLEGEL5005
78146-701-60Clean and Pure Hand Sanitizer Gel60 mL in 1 BOTTLEGEL605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78146-701CLEAN AND PURE HAND SANITIZER GEL (ALCOHOL) GEL [EVESEL CO., LTD.]5Legacy NDC, 6 package rows20210111_a6227706-76bb-be60-e053-2a95a90a72ec.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78146-70178146-701-50, 78146-701-10, 78146-701-60, 78146-701-12, 78146-701-30, 78146-701-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
POLYSORBATE 60CAL22UVI4MIACT
PANTHENOLWV9CM0O67ZIACT
BUTANEDIOL (MIXED ISOMERS)TMS4MGA0H4IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b878d71c-dfe7-100f-e053-2995a90af42fa6227706-76bb-be60-e053-2a95a90a72ec2021-01-09WarningsExact identifier
spl id: b878d71c-dfe7-100f-e053-2995a90af42f
spl set id: a6227706-76bb-be60-e053-2a95a90a72ec

Reported adverse events (FAERS/openFDA)#

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