FDA.reportPublic FDA data

ULTRACLEAN

Manufacturer
ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:56

Label at a glance#

ProductULTRACLEAN ANTIBACTERIAL HANDSOAP
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Storage and handling

Store between 59-86ºF (15-30ºC). Avoid freezing and excessive heat above 104ºF (40ºC). May discolor certain fabrics and surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)  

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use(s)

INDICATIONS & USAGE SECTION

For hand washing to help reduce bacteria and germs on the skin.

Warnings

WARNINGS SECTION

• For external use only.

• Not edible, Don’t drink.

• Prolonged skin contact may cause temporary irritation.

Do not Use

• in children less than 2 months of age.

• on open skin wounds.

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.

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.

Direction

DOSAGE & ADMINISTRATION SECTION

• Pump into hands, wet as needed.

• Lather vigorously for at least 15 seconds.

• Wash hands, rinse thoroughly and dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

Store between 59-86ºF (15-30ºC). Avoid freezing and excessive heat above 104ºF (40ºC). May discolor certain fabrics and surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA,

Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid,

Tocopheryl Acetate, Panthenol.

SPL UNCLASSIFIED SECTION

PLUS FORMULA PROTECTION

instant effect

Clean, Sanitize and Moisture

Free of paraben, dye and phthalates

ANTIBACTERIAL LIQUID SOAP

– Sanitizing formula to help reduce cross-contamination.

– Hands feel smooth, soft and refreshed.

Distributed by Civilon LLC

Clifton, NJ, 07011

MADE IN TURKEY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80374-101-502022-01-28C16284748780-1d6a99b39-6292-a426-e053-dadaa90af4c2Ultraclean ® ANTIBACTERIAL HAND SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80374-101-50ULTRACLEANANTIBACTERIAL HANDSOAP500 mL in 1 BOTTLELIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80374-101ULTRACLEAN ANTIBACTERIAL HANDSOAP (BENZALKONIUM CHLORIDE) LIQUID [ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20200923_cb1247f1-56fd-4263-9ccc-23d5ecc9523a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80374-10180374-101-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERINPDC6A3C0OXIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
SODIUM BENZOATEOJ245FE5EUIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
LIME OILUZH29XGA8GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT

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
0ec86f00-18c8-4d66-bcd1-84c33c8a98e9cb1247f1-56fd-4263-9ccc-23d5ecc9523a2020-09-01WarningsExact identifier
spl id: 0ec86f00-18c8-4d66-bcd1-84c33c8a98e9
spl set id: cb1247f1-56fd-4263-9ccc-23d5ecc9523a

Reported adverse events (FAERS/openFDA)#

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