FDA.reportPublic FDA data

CLORALEN TM ANTIBACTERIAL WIPES

Manufacturer
INDELPA, S.A DE C.V
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:48

Label at a glance#

ProductCLORALEN TM ANTIBACTERIAL WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Antibacterial

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM, CHLORIDE 0.125%

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

If you are allergic to any of the ingredients

OTC - WHEN USING SECTION

Do not get into eyes.

If contact occurs, rinse throughly with water

OTC - STOP USE SECTION

If irritation or rash develops and continues for more than 72 hours

OTC - ASK DOCTOR SECTION

If irritation or rash develops and continues for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INSTRUCTIONS FOR USE SECTION

- wet hands throughly with product and allow to dry.

-discard wipe in trash receptacle after use. Do not flush

- chuldren under 6 years af age should be supervised whe using this product

INACTIVE INGREDIENT SECTION

water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol

DOSAGE & ADMINISTRATION SECTION

Topical admistration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISPLAY CLORALENDISPLAY CLORALEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2276303benzalkonium Cl 0.125 % Medicated PadPSN2
2276303benzalkonium chloride 1.25 MG/ML Medicated PadSCD2
2276303benzalkonium chloride 0.125 % Medicated WipeSY2
2276303benzalkonium chloride 0.125 % Topical ClothSY2
2276303benzalkonium chloride 0.125 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70697-802-012024-01-30C16284748780-11030e365-353d-111a-e063-dadaa90a10e2ae4556b5-d778-558a-e053-2a95a90ae1b1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-802-01CLORALEN TM ANTIBACTERIAL WIPES0.375 mg in 1 POUCHLIQUID0.3752
70697-802-01CLORALEN TM ANTIBACTERIAL WIPES24 in 1 CASELIQUID242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-802CLORALEN TM ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) LIQUID [INDELPA, S.A DE C.V]2Legacy NDC, 2 package rows20220114_ae4556b5-d778-558a-e053-2a95a90ae1b1.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70697-80270697-802-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
d57ba6b7-6577-8b3d-e053-2995a90ad7d3ae4556b5-d778-558a-e053-2a95a90ae1b12022-01-13WarningsExact identifier
spl id: d57ba6b7-6577-8b3d-e053-2995a90ad7d3
spl set id: ae4556b5-d778-558a-e053-2a95a90ae1b1

Reported adverse events (FAERS/openFDA)#

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