FDA.reportPublic FDA data

CLEANSOL ANTIBACTERIAL WET WIPES

Manufacturer
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:43

Label at a glance#

ProductCLEANSOL ANTIBACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

To decrease bacteria on skin.

Dosage and administration

• Remove lid, open cap, thread wipe through slit and close lid. • Gently remove wipe, clean skin thoroughly, and allow hands to dry. • Do not flush, dispose in a waste basket, and close lid after use. • Store at room temperature and protect from sun exposure. • For children under 2 years old, ask a doctor before use.

Storage and handling

Production date, expiration date, and lot number are printed on the package.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on skin.

Warnings

WARNINGS SECTION

For external use only

When using this product, avoid contacting eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Remove lid, open cap, thread wipe through slit and close lid.

• Gently remove wipe, clean skin thoroughly, and allow hands to dry.

• Do not flush, dispose in a waste basket, and close lid after use.

• Store at room temperature and protect from sun exposure.

• For children under 2 years old, ask a doctor before use.

Other information

STORAGE AND HANDLING SECTION

Production date, expiration date, and lot number are printed on the package.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Phenoxyethanol, Peg 7 Glyceryl Cocoate, Polysorbate 20, Glycerin, Perfume (Lime Oil), Cocamidopropyl Betaine, Citric Acid, Limonene, Hexyl Cinnamal, Citral, Citronellol, Geraniol, Benzyl Benzoate, Linalool.

SPL UNCLASSIFIED SECTION

Kills 99.9% of Germs*

Free of

Alcohol

Parabens

Dyes

Phthalates

DERMATOLOGICALLY TESTED

Distributed by

Oceanline LLC

2 Andrews Dr, Ste 5

Woodland Park, NJ 07424

Questions & Comments

+1-201-562-8403

info@oceanlinebrands.com

• Decreases bacteria on skin.

• Removes dirt and makes skin clean and smooth.

• Provides skin with a nice lime scent.

• Leaves no stickiness or residue on skin.

• Is skin friendly, free of alcohol, parabens, dyes, and phthalates.

TO OPEN CANISTER:

Remove lid, open cap

Thread wipes through slit

Close both lid and cap

Made in Turkey

DO NOT FLUSH. Dispose in a waste basket after use.

*Kills 99.9% of germs that may cause illness.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

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
78089-048-012022-01-28C16284748780-1d6a99b39-af7e-a426-e053-dadaa90af4c2CLEANSOL ANTIBACTERIAL WET WIPES Lime Scent
78089-048-022022-01-28C16284748780-1d6a99b39-af7e-a426-e053-dadaa90af4c2CLEANSOL ANTIBACTERIAL WET WIPES Lime Scent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78089-048-01CLEANSOL ANTIBACTERIAL WET WIPES3.24 g in 1 PACKAGECLOTH3.241
78089-048-01CLEANSOL ANTIBACTERIAL WET WIPES100 in 1 CANISTERCLOTH1001
78089-048-02CLEANSOL ANTIBACTERIAL WET WIPES100 in 1 PACKETCLOTH1001
78089-048-02CLEANSOL ANTIBACTERIAL WET WIPES3.24 g in 1 PACKAGECLOTH3.241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78089-048CLEANSOL ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [ENDEKS KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 4 package rows20200919_a173558e-2f56-4561-88bf-e40643e7ee98.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
78089-04878089-048-01, 78089-048-02

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
c5156774-03b4-4c04-918d-1e79956b8086a173558e-2f56-4561-88bf-e40643e7ee982020-09-15WarningsExact identifier
spl id: c5156774-03b4-4c04-918d-1e79956b8086
spl set id: a173558e-2f56-4561-88bf-e40643e7ee98

Reported adverse events (FAERS/openFDA)#

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