FDA.reportPublic FDA data

Anti-Bacter Hand Sanitizer Melon

Manufacturer
ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI
Effective date
2021-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:33

Label at a glance#

ProductAnti-Bacter Hand Sanitizer Melon
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 hand, rub hands together brikly 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% v/v

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

OTC - DO NOT USE SECTION

  • on broken, cut or irritated skin

When using this product

OTC - WHEN USING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN 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

  • 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 hand, rub hands together brikly 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

AQUA (WATER), GLYCERIN, ALOE BARBADENSIS LEAF JUICE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER / CARBOMER*, MANNITOL, MICROCRYSTALLINE CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE POWDER, TOCOPHERYL ACETATE, ALGIN, PARFUM, AMINOMETHYL PROPANOL, BENZOPHENONE-3, POTASSIUM SORBATE, SODIUM BENZOATE, LIMONENE, CITRAL, CI 74260, CI 77492 (IRON OXIDES), CI 19140, (FD&C YELLOW 5), CI 17200 (D&C RED 33).
*The letter next to the batch number means:
A-acrylates/C10-30 alkyl acrylate crosspolymer B-carbomer

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle8Bottle8Bottle9Bottle9

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80457-000-012022-07-29C16284748780-1e4f33bdf-b104-d8a0-e053-dadaa90a6e4eAnti-Bacter Hand Sanitizer 70% Ethyl Alcohol Melon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80457-000-01Anti-Bacter Hand Sanitizer Melon200 mL in 1 BOTTLEGEL2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80457-000ANTI-BACTER HAND SANITIZER MELON (ALCOHOL) GEL [ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI]3Legacy NDC, 1 package rows20210226_b2e8a00e-0aeb-7b49-e053-2a95a90abddf.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80457-00080457-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM ALGINATEC269C4G2ZQIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
OXYBENZONE95OOS7VE0YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
LIMONENE OXIDE, (+)-278IM94GXBIACT
CITRALT7EU0O9VPPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
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
bc2b337b-60a3-0f05-e053-2995a90a77b5b2e8a00e-0aeb-7b49-e053-2a95a90abddf2021-02-25WarningsExact identifier
spl id: bc2b337b-60a3-0f05-e053-2995a90a77b5
spl set id: b2e8a00e-0aeb-7b49-e053-2a95a90abddf

Reported adverse events (FAERS/openFDA)#

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