FDA.reportPublic FDA data

ULTRACLEAN X

Manufacturer
BOSS KOZMETIK VE DIS TICARET ANONIM SIRKETI
Effective date
2020-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:09

Label at a glance#

ProductULTRACLEAN X ANTIBACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Hand sanitizer wipes to help reduce bacteria and germs on the skin. Recommended for repeated use.

Dosage and administration

• Take wipe and rub thoroughly over all of both hands, Wet hands thoroughly with wipe and allow to dry, discard after use. • Children under 6 years of age should be supervised when using this product.

Storage and handling

Store at room temperature. Keep tightly closed when not use. Dispose of used wipe in trash. Do not flush.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer wipes to help reduce bacteria and germs on the skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

When using this product avoid contacting with eyes.

In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

• Take wipe and rub thoroughly over all of both hands, Wet hands thoroughly with wipe and allow to dry, discard after use.

• Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature. Keep tightly closed when not use. Dispose of used wipe in trash. Do not flush.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aqua (Water),  Benzoic Acid, Dehydroacetic Acid, Dicaprylyl Carbonate, Glycerin, Lauryl Glucoside, Lime Oil, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate

SPL UNCLASSIFIED SECTION

PLUS FORMULA PROTECTION

instant effect!

Free of Paraben, Dye and Phthalates

SANITIZER

ANTIBACTERIAL WET WIPES

FOR HAND SANITIZING TO DECREASE BACTERIA AND GERMS ON THE SKIN

• Sanitizing formula to help reduce cross-contamination and risk of infection.

• Leaves no stickiness or residue on hands.

• Hands feel smooth, soft and refreshed.

To Open Package:

• Flip open dispensing lid 

• Locate wipe at center of roll and thread through small opening in lid

• For best results dispense wipes at an angle 

• Always close lid securely between uses to retain moisture

TO DISPOSE WIPE: Place in a waste basket after use.

DO NOT FLUSH

Distributed by

Civilon LLC

Clifton, NJ, 07011

MADE IN TURKEY

OZONE FRIENDLY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80445-101-722021-07-23C16284748780-1c7ccaba7-1bf6-fd44-e053-dadaa90aa01bUltraclean X ® ANTIBACTERIAL WET WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80445-101-72ULTRACLEAN XANTIBACTERIAL WET WIPES72 in 1 CANISTERCLOTH721
80445-101-72ULTRACLEAN XANTIBACTERIAL WET WIPES4 mL in 1 PACKAGECLOTH41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80445-101ULTRACLEAN X ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [BOSS KOZMETIK VE DIS TICARET ANONIM SIRKETI]1Legacy NDC, 2 package rows20200912_e971982e-ff03-4ee4-bbf3-7f621fe5f12e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80445-10180445-101-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
LIME OILUZH29XGA8GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT

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
f396a872-b16c-49f1-a365-01f844fe8fdbe971982e-ff03-4ee4-bbf3-7f621fe5f12e2020-09-04WarningsExact identifier
spl id: f396a872-b16c-49f1-a365-01f844fe8fdb
spl set id: e971982e-ff03-4ee4-bbf3-7f621fe5f12e

Reported adverse events (FAERS/openFDA)#

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