FDA.reportPublic FDA data

ALCOHOL

Manufacturer
ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI
Effective date
2021-03-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:39:11

Label at a glance#

ProductAnti Bacter Hand Sanitizer Med Clean No Water Needed with Aloe Vera and Glycerine
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

for travel, shopping, school, work and home use to help reduce bacteria on the skin for use when water and soap are not available recommended for repeated uses

Dosage and administration

place enough gel in your palms to thoroughly cover your hands, rub hands together briskly until dry children under 6 years of age should be supervised when using Anti-Bacter Hand Sanitizer not recommended for infants

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for travel, shopping, school, work and home use
  • to help reduce bacteria on the skin
  • for use when water and soap are not available
  • recommended for repeated uses

Warnings:

WARNINGS SECTION

For External use only: hands

  • flammable, keep away from sources of heat or fire
  • do not use on broken, cut or irritated skin

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes, if contact occurs, rinse thoroughly with water, 

stop using and ak a doctor

OTC - STOP USE SECTION

if irritation or redness develops or lasts 

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • place enough gel in your palms to thoroughly cover your hands, rub hands together briskly until dry
  • children under 6 years of age should be supervised when using Anti-Bacter Hand Sanitizer
  • not recommended for infants

Other information

SPL UNCLASSIFIED SECTION

  • store at a temperature below 104°F (40°C)
  • may discolor certain fabrics and surfaces

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl acrylate crosspolymer/carbomer*, mannitol, microcrystaline cellylose, hydroxypropyl methylcallulose, aloe barbadensis leaf juice powder, tocopheryl acecate, algin, parfum (fragrance), aminomethyl propanol, benzophenone-3, potassium sorbate, sodium benzoate, CI 74260, CI 77492 ( Iron Oxide), CI 19140 (FD&C Yellow 5), CI 42090 (Blue 1).

*The letter next to the batch number means:

A- acrylates/C1O-3O alkyl acrylate crosspolymer B-carbomer

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

002002

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
80457-001-012022-07-29C16284748780-1e4f33bdf-a6c9-d8a0-e053-dadaa90a6e4eAnti-Bacter Hand Sanitizer Med-Clean, 70% Ethyl Alcohol No Water Needed with Aloe Vera and Glycerine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80457-001-01Anti Bacter Hand Sanitizer Med Clean No Water Needed with Aloe Vera and Glycerine200 mL in 1 BOTTLEGEL2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80457-001ANTI BACTER HAND SANITIZER MED CLEAN NO WATER NEEDED WITH ALOE VERA AND GLYCERINE (ALCOHOL) GEL [ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI]5Legacy NDC, 1 package rows20210326_b2e8a00e-0af1-7b49-e053-2a95a90abddf.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80457-00180457-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT

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
be607a15-4e43-f635-e053-2995a90a8eb0b2e8a00e-0af1-7b49-e053-2a95a90abddf2021-03-25WarningsExact identifier
spl id: be607a15-4e43-f635-e053-2995a90a8eb0
spl set id: b2e8a00e-0af1-7b49-e053-2a95a90abddf

Reported adverse events (FAERS/openFDA)#

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