FDA.reportPublic FDA data

LACTONE HAND SANITIZER

Manufacturer
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI | HARDAL GLOBAL CONSULTING LLC.
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:26

Label at a glance#

ProductLACTONE HAND SANITIZER
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

Alcohol 80% 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

Glycerin, Carbomer, Thiethanlamine, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Producer

ALL ONE KOZMETIK SAN. DIS. TIC. A. S.

Sutluce Mahallesi

Uzunbayir Sokak No:44/4

Beyoglu/Istanbul

PRD: 01.04.2020

EXP: 01.04.2023

LOT: AL006220

MADE IN TURKEY

Dermal Disinfectant

HAND SANITIZER GEL

Kills 99.9% of germs without water

For External Use Only

1000 and 5001000 and 500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138694587576540GTIN-13: 8694587576540
EAN-13: 8694587576540
GTIN storage (14 digits): 08694587576540		aa7451df-dfc3-6395-e053-2995a90a1fcd.jpg, collagePlyfah (1).jpg
BarcodeEAN-138694587576557GTIN-13: 8694587576557
EAN-13: 8694587576557
GTIN storage (14 digits): 08694587576557		aa7451df-dfc3-6395-e053-2995a90a1fcd.jpg, collagePlyfah (1).jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75348-606-012021-07-23C16284748780-1c7ccaba7-181e-fd44-e053-dadaa90aa01bHand Sanitizer 606
75348-606-502021-07-23C16284748780-1c7ccaba7-181e-fd44-e053-dadaa90aa01bHand Sanitizer 606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75348-606-01LACTONE HAND SANITIZER1000 mL in 1 BOTTLE, PLASTICGEL10001
75348-606-50LACTONE HAND SANITIZER500 mL in 1 BOTTLE, PLASTICGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75348-606LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]1Legacy NDC, 2 package rows20200715_aa74394e-f181-2ab5-e053-2995a90a6fef.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
75348-60675348-606-01, 75348-606-50

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
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT

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
aa743915-71a8-9693-e053-2a95a90aa9fcaa74394e-f181-2ab5-e053-2995a90a6fef2020-07-15WarningsExact identifier
spl id: aa743915-71a8-9693-e053-2a95a90aa9fc
spl set id: aa74394e-f181-2ab5-e053-2995a90a6fef

Reported adverse events (FAERS/openFDA)#

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