FDA.reportPublic FDA data

Alclene Hand Sanitizer

Manufacturer
Global Cosmetics (China) Company Limited
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:24:16

Label at a glance#

ProductAlclene Hand Sanitizer
Active ingredientALCOHOL
Label structure10 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 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F) May discolour fabrics

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses[s] : Hand Sanitizer to help reduce bacteria on skin.

WARNINGS SECTION

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

Do not use

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

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 ash 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 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
  • May discolour fabrics

INACTIVE INGREDIENT SECTION

Inactive Ingredients : Aloe Barbadensis Leaf Juice, Carbomer, Citric Acid, Denatonium Benzoate, Glycerin, Triethanolamine, Water (Aqua)

OTC - QUESTIONS SECTION

Questions or comments? Emergency Contact Chemtel™ North America: 1-800-255-3924

SPL UNCLASSIFIED SECTION

Kills 99.9% of Germs

With Glycerin and Aloe Vera extracts

Distributor: Nuten Custom Manufacturing Ltd.

1105 Clay Ave, Unit#7, Burlington, ON, L7L 0A1

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
71650-01071650-010-01, 71650-010-02, 71650-010-03, 71650-010-04, 71650-010-05

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
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
d08714dd-54e3-4bb3-86bb-57aa0403121c3b101643-436b-4fc7-adaf-42f06174e6dd2023-03-31WarningsExact identifier
spl set id: 3b101643-436b-4fc7-adaf-42f06174e6dd

Reported adverse events (FAERS/openFDA)#

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