FDA.reportPublic FDA data

Antiseptic Liquid

Manufacturer
ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:13

Label at a glance#

ProductAntiseptic Liquid
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use

Dosage and administration

• Squeeze a few pumps into your palms, foam with water and rinse. • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient 

OTC - ACTIVE INGREDIENT SECTION

0,5% (w/w) Benzalkonium Chloride

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• 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

• Squeeze a few pumps into your palms, foam with water and rinse.
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionised Water, Cocamidopropyl Betaine, Sodium Cocoamphoacetate, Lauryl Glucoside, Glycerin, PEG-150 Distearate, Hydrogenated Castor Oil,
Sodium Chloride, Citric Acid, CI 42090

Questions?

OTC - QUESTIONS SECTION

+1-646-301-0044
You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Manufactured by: Itimat Kozmetik Urunleri San. Ve Tic. A.S.
Karadeniz District. M.Akif Avenue 1117/1 Street No:8
Gaziosmanpasa / ISTANBUL
COUNTRY OF ORIGIN: TURKEY
Batch No:

Expiry:

www.fonex.com.tr - info@fonex.com.tr

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN1
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD1
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79392-102-012022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-022022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-032022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-042022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-052022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-062022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-072022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-082022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-092022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-102022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-112022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-122022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-132022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-142022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-152022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-162022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-172022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP
79392-102-182022-01-28C16284748780-1d6a99b39-f973-a426-e053-dadaa90af4c2FONEX ANTISEPTIC LIQUID SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79392-102-01Antiseptic Liquid50 mL in 1 BOTTLESOAP501
79392-102-02Antiseptic Liquid100 mL in 1 BOTTLESOAP1001
79392-102-03Antiseptic Liquid150 mL in 1 BOTTLESOAP1501
79392-102-04Antiseptic Liquid250 mL in 1 BOTTLESOAP2501
79392-102-05Antiseptic Liquid500 mL in 1 BOTTLESOAP5001
79392-102-06Antiseptic Liquid750 mL in 1 BOTTLESOAP7501
79392-102-07Antiseptic Liquid1000 mL in 1 BOTTLESOAP10001
79392-102-08Antiseptic Liquid1500 mL in 1 BOTTLESOAP15001
79392-102-09Antiseptic Liquid2000 mL in 1 BOTTLESOAP20001
79392-102-10Antiseptic Liquid2500 mL in 1 BOTTLESOAP25001
79392-102-11Antiseptic Liquid3000 mL in 1 BOTTLESOAP30001
79392-102-12Antiseptic Liquid3500 mL in 1 BOTTLESOAP35001
79392-102-13Antiseptic Liquid4000 mL in 1 BOTTLESOAP40001
79392-102-14Antiseptic Liquid4500 mL in 1 BOTTLESOAP45001
79392-102-15Antiseptic Liquid5000 mL in 1 BOTTLESOAP50001
79392-102-16Antiseptic Liquid10000 mL in 1 BOTTLESOAP100001
79392-102-17Antiseptic Liquid20000 mL in 1 BOTTLESOAP200001
79392-102-18Antiseptic Liquid50 mL in 1 BOTTLESOAP501
79392-102-18Antiseptic Liquid36 in 1 BOXSOAP361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79392-102ANTISEPTIC LIQUID (BENZALKONIUM CHLORIDE) SOAP [ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 19 package rows20200809_c384f8dd-cb56-4696-b869-5e7b1fd0019b.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79392-10279392-102-01, 79392-102-02, 79392-102-03, 79392-102-04, 79392-102-05, 79392-102-06, 79392-102-07, 79392-102-08, 79392-102-09, 79392-102-10, 79392-102-11, 79392-102-12, 79392-102-13, 79392-102-14, 79392-102-15, 79392-102-16, 79392-102-17, 79392-102-18

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
GLYCERINPDC6A3C0OXIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
640b635e-3db4-4ba2-a813-371704737394c384f8dd-cb56-4696-b869-5e7b1fd0019b2020-07-20WarningsExact identifier
spl id: 640b635e-3db4-4ba2-a813-371704737394
spl set id: c384f8dd-cb56-4696-b869-5e7b1fd0019b

Reported adverse events (FAERS/openFDA)#

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