FDA.reportPublic FDA data

Cloralen Antibacterial Wipes

Manufacturer
Industrias Alen, S.A. de C.V.
Effective date
2021-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:04

Label at a glance#

ProductCloralen Antibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use:

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product,

OTC - WHEN USING SECTION

do not use in or near the eyes, in case of contact, rinse eyes thoroughly with water.

Stop using and ask a doctor if

OTC - STOP USE SECTION

Irritation or rash appears and lasts.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Children under 6 years of age should be supervised when using CLORALENTM ANTIBACTERIAL WIPES.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Laurylamine Dipropylenediamine, Propylene Glycol USP, Phenoxyethanol, Fragrance, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium 
Cocoamphoacetate, Isopropyl Alcohol, Citric Acid, Tetrasodium EDTA, Laureth-7 Citrate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81350-00281350-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
N-(3-AMINOPROPYL)-N-DODECYL-1,3-PROPANEDIAMINEPCJ6308JUEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
GLYCERINPDC6A3C0OXIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
ISOPROPYL ALCOHOLND2M416302IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
LAURETH-7Z95S6G8201IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
0a1074dc-86b7-8bd1-e063-6394a90aa7b0bd95b6c0-0666-9481-e053-2a95a90a101f2023-11-13WarningsExact identifier
spl set id: bd95b6c0-0666-9481-e053-2a95a90a101f

Reported adverse events (FAERS/openFDA)#

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