FDA.reportPublic FDA data

Activex Antibacterial Hand Sanitizer Active

Manufacturer
Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi
Effective date
2020-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:27

Label at a glance#

ProductActivex Antibacterial Hand Sanitizer Active
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

-Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

- For external use only.
- Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

-irritation and redness develop

-Condition persists for more than 72 hours

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

-Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

- Store in original packaging in a cool and dry place, out of direct sunlight.

- May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, acrylates/C 10-300 alkyl acrylate crosspolymer, fragrance, triethanolamine, isopropyl myristate.

Questions or comments

OTC - QUESTIONS SECTION

1 (224) - 408-0663

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64309-001-012023-01-30C16284748780-1f386c64a-1838-0266-e053-dadaa90a7c1aActivex Antibacterial Hand Sanitizer Active

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64309-001-01Activex Antibacterial Hand Sanitizer Active100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64309-001ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE (ALCOHOL) GEL [EVYAP SABUN YAG GLISERIN SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20201027_b295f92f-3f26-773b-e053-2995a90a62ed.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64309-00164309-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
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
b295f945-9042-b131-e053-2995a90ad5f6b295f92f-3f26-773b-e053-2995a90a62ed2020-10-26WarningsExact identifier
spl id: b295f945-9042-b131-e053-2995a90ad5f6
spl set id: b295f92f-3f26-773b-e053-2995a90a62ed

Reported adverse events (FAERS/openFDA)#

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