FDA.reportPublic FDA data

Cleansol Antibacterial Wet Wipes

Manufacturer
Oceanline LLC
Effective date
2024-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:49

Label at a glance#

ProductCleansol Antibacterial Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours

Keep out of reach of children

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cleansol antibacterial wet wipes 100 wipes lime scentcleansol antibacterial wet wipes 100 wipes lime scentcleansol antibacterial wet wipes drug factscleansol antibacterial wet wipes drug facts

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
84247-002-012026-01-29C16284748780-149896155-a2ae-586f-e063-e6dba90add9015b12d2d-ea55-db0e-e063-6394a90a924a
84247-002-022026-01-29C16284748780-149896155-a2ae-586f-e063-e6dba90add9015b12d2d-ea55-db0e-e063-6394a90a924a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84247-002-01Cleansol Antibacterial Wet Wipes3.24 g in 1 PATCHCLOTH3.241
84247-002-01Cleansol Antibacterial Wet Wipes100 in 1 POUCHCLOTH1001
84247-002-02Cleansol Antibacterial Wet Wipes3.24 g in 1 PATCHCLOTH3.241
84247-002-02Cleansol Antibacterial Wet Wipes100 in 1 CANISTERCLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84247-002CLEANSOL ANTIBACTERIAL WET WIPES (BENZALKONIUM CHOLORIDE) CLOTH [OCEANLINE LLC]14 package rows20240501_15b12d2d-ea55-db0e-e063-6394a90a924a.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84247-00284247-002-01, 84247-002-02

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

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
15b12d2d-ea56-db0e-e063-6394a90a924a15b12d2d-ea55-db0e-e063-6394a90a924a2024-04-09WarningsExact identifier
spl id: 15b12d2d-ea56-db0e-e063-6394a90a924a
spl set id: 15b12d2d-ea55-db0e-e063-6394a90a924a

Reported adverse events (FAERS/openFDA)#

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