FDA.reportPublic FDA data

Dr. Alpha Hand Cleaner

Manufacturer
EVESEL CO., LTD | EVESEL CO., LTD.
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:44

Label at a glance#

ProductDr. Alpha Hand Cleaner
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 75% 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

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000ml1000ml3785ml3785ml120ml120ml300ml300ml60ml60ml500ml500ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78146-756-102023-01-30C16284748780-1f386c649-fc55-0266-e053-dadaa90a7c1aDr. Alpha hand cleaner 75% Evesel
78146-756-112023-01-30C16284748780-1f386c649-fc55-0266-e053-dadaa90a7c1aDr. Alpha hand cleaner 75% Evesel
78146-756-122023-01-30C16284748780-1f386c649-fc55-0266-e053-dadaa90a7c1aDr. Alpha hand cleaner 75% Evesel
78146-756-302023-01-30C16284748780-1f386c649-fc55-0266-e053-dadaa90a7c1aDr. Alpha hand cleaner 75% Evesel
78146-756-502023-01-30C16284748780-1f386c649-fc55-0266-e053-dadaa90a7c1aDr. Alpha hand cleaner 75% Evesel
78146-756-602023-01-30C16284748780-1f386c649-fc55-0266-e053-dadaa90a7c1aDr. Alpha hand cleaner 75% Evesel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78146-756-10Dr. Alpha Hand Cleaner3785 mL in 1 BOTTLEGEL37852
78146-756-11Dr. Alpha Hand Cleaner1000 mL in 1 BOTTLEGEL10002
78146-756-12Dr. Alpha Hand Cleaner120 mL in 1 BOTTLEGEL1202
78146-756-30Dr. Alpha Hand Cleaner300 mL in 1 BOTTLEGEL3002
78146-756-50Dr. Alpha Hand Cleaner500 mL in 1 BOTTLEGEL5002
78146-756-60Dr. Alpha Hand Cleaner60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78146-756DR. ALPHA HAND CLEANER (ALCOHOL) GEL [EVESEL CO., LTD]2Legacy NDC, 6 package rows20210111_a7d3e478-923b-b4e2-e053-2a95a90ab808.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78146-75678146-756-50, 78146-756-10, 78146-756-60, 78146-756-12, 78146-756-30, 78146-756-11

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
TROLAMINE9O3K93S3TKIACT
BUTANEDIOL (MIXED ISOMERS)TMS4MGA0H4IACT
CARBOMER 9804Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
PANTHENOLWV9CM0O67ZIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT

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
b87992ce-fabb-496c-e053-2a95a90a9dcca7d3e478-923b-b4e2-e053-2a95a90ab8082021-01-09WarningsExact identifier
spl id: b87992ce-fabb-496c-e053-2a95a90a9dcc
spl set id: a7d3e478-923b-b4e2-e053-2a95a90ab808

Reported adverse events (FAERS/openFDA)#

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