FDA.reportPublic FDA data

ULTRACLEAN ANTIBACTERIAL WET WIPES

Manufacturer
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
Effective date
2020-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:19

Label at a glance#

ProductULTRACLEAN 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 surfaces 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 in 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 surfaces 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 in use.

Dispose of used wipe in trash. Do not flush.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Phenoxyethanol, Peg 7 glyceryl cocoate, Polysorbate 20, Glycerin, Lime oil, Cocamidopropyl betaine, Citric acid, Limonene, Hexyl Cinnamal, Citral, Citronellol, Geraniol, Benzyl Benzoate, Linalool.

SPL UNCLASSIFIED SECTION

PLUS FORMULA

PROTECTION

instant effect!

Free of Paraben, Dye and Phthalates

SANITIZING WIPES

5.70 IN X 8.26 IN (14.5cm x 21cm)

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

16.29 OZ. (462 g) ± 5%

Distributed by

Civilon LLC

Clifton, NJ, 07011

MADE IN TURKEY

OZONE FRIENDLY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78089-030-012022-01-28C16284748780-1d6a99b39-df90-a426-e053-dadaa90af4c2Ultra Clean ® ANTIBACTERIAL WET WIPES
78089-030-022022-01-28C16284748780-1d6a99b39-df90-a426-e053-dadaa90af4c2Ultra Clean ® ANTIBACTERIAL WET WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78089-030-01ULTRACLEAN ANTIBACTERIAL WET WIPES72 in 1 PACKETCLOTH721
78089-030-01ULTRACLEAN ANTIBACTERIAL WET WIPES4.11 g in 1 PACKAGECLOTH4.111
78089-030-02ULTRACLEAN ANTIBACTERIAL WET WIPES72 in 1 PACKETCLOTH721
78089-030-02ULTRACLEAN ANTIBACTERIAL WET WIPES3.64 g in 1 PACKAGECLOTH3.641

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78089-030ULTRACLEAN ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [ENDEKS KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 4 package rows20200731_c52e5540-1cfb-4d69-ad8b-251736c86c78.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78089-03078089-030-01, 78089-030-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
LIME OILUZH29XGA8GIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
CITRALT7EU0O9VPPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
GERANIOLL837108USYIACT
BENZYL BENZOATEN863NB338GIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
366e5319-2c4d-45b5-9214-b73ea7286676c52e5540-1cfb-4d69-ad8b-251736c86c782020-07-24WarningsExact identifier
spl id: 366e5319-2c4d-45b5-9214-b73ea7286676
spl set id: c52e5540-1cfb-4d69-ad8b-251736c86c78

Reported adverse events (FAERS/openFDA)#

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