FDA.reportPublic FDA data

LACTONE HAND SANITIZER

Manufacturer
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:56

Label at a glance#

ProductLACTONE HAND SANITIZER
Active ingredientALCOHOL
Label structure9 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

OTC - PURPOSE SECTION

Antiseptic

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

- in children less than 2 months of age

- on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

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

- 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, Triethanolamine, purified water USP

SPL UNCLASSIFIED SECTION

Kills 99.9% of germs without water

For External Use Only

MADE IN TURKEY

Producer

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

Sutluce Mahallesi Uzunbayir Sokak No. 44/4 Beyoglu / Istanbu

PRD: 01.04.2020

EXP: 01.04.2023

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75348-606-052021-07-23C16284748780-1c7ccaba7-1374-fd44-e053-dadaa90aa01bLACTONE HAND SANITIZER
75348-606-102021-07-23C16284748780-1c7ccaba7-1374-fd44-e053-dadaa90aa01bLACTONE HAND SANITIZER
75348-606-252021-07-23C16284748780-1c7ccaba7-1374-fd44-e053-dadaa90aa01bLACTONE HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75348-606-05LACTONE HAND SANITIZER50 mL in 1 BOTTLEGEL501
75348-606-10LACTONE HAND SANITIZER100 mL in 1 BOTTLEGEL1001
75348-606-25LACTONE HAND SANITIZER250 mL in 1 BOTTLEGEL2501

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, 3 package rows20200425_b996b2fb-59db-4435-8b21-f11baf6de491.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
75348-60675348-606-05, 75348-606-10, 75348-606-25

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
e66bbd86-77e5-4bda-9b6c-7eaf6f7639dcb996b2fb-59db-4435-8b21-f11baf6de4912020-04-22WarningsExact identifier
spl id: e66bbd86-77e5-4bda-9b6c-7eaf6f7639dc
spl set id: b996b2fb-59db-4435-8b21-f11baf6de491

Reported adverse events (FAERS/openFDA)#

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