FDA.reportPublic FDA data

SEGUCLEAN

Manufacturer
Productos y Servicios de Limpieza Seguclean S.A. de C.V.
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:17

Label at a glance#

ProductSEGUCLEAN
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

APPLY TO THE PALM OF THE HAND, RUB COVERING BOTH PALMS AND FINGERTIPS, RINSE BOTH HANDS AND ALLOW TO DRY.

Dosage and administration

APPLY TO THE PALM OF THE HAND, RUB COVERING BOTH HANDS AND FINGERTIPS, RINSE BOTH HANDS AND ALLOW TO DRY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE, TRICLOSAN

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERYN, AROMATIC ESSENCE, COCONUT AMIDE AND SODIUM LAURYL ETHER SULFATE

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

APPLY TO THE PALM OF THE HAND, RUB COVERING BOTH PALMS AND FINGERTIPS, RINSE BOTH HANDS AND ALLOW TO DRY.

DO NOT USE

OTC - DO NOT USE SECTION

DO NOT USE IN CHILDREN UNDER TWO MONTHS OF AGE.

DON NOT USE IN EXPOSED WOUNDS

STOP USE

OTC - STOP USE SECTION

STOP USING THE PRODUCT AND CONSULT A DOCTOR IF IRRITATION OR SKIN RASH APPEARS AND PERSISTS.
THESE CAN BE SIGNS OF A SERIOUS MEDICAL CONDITION.

PURPOSE

OTC - PURPOSE SECTION

PURPOSE ANTIBACTERIAL

KEEP OUT OF THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. IN CASE OF INGESTION, SEEK MEDICAL ADVICE IMMEDIATELY OR CONTACT A TOXIC SUBSTANCES CONTROL CENTER.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

THE USE OF THIS PRODUCT IN BY CHILDREN UNDER 6 YEARS OLD MUST BE SUPERVISED BY AND OLDER PERSON.

WARNINGS

WARNINGS SECTION

KEEP OUR OF THE REACH OF CHILDREN

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

APPLY TO THE PALM OF THE HAND, RUB COVERING BOTH HANDS AND FINGERTIPS, RINSE BOTH HANDS AND ALLOW TO DRY.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHAMPOO SANITIZER 250 mLSHAMPOO SANITIZER 250 mLSHAMPOO SANITIZER 500 mLSHAMPOO SANITIZER 500 mLSHAMPOO SANITIZER 1000 mLSHAMPOO SANITIZER 1000 mLSHAMPOO SANITIZER 5000 mLSHAMPOO SANITIZER 5000 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79594-4000-12022-01-28C16284748780-1d6a99b39-431d-a426-e053-dadaa90af4c2SANITIZING SHAMPOO
79594-4000-22022-01-28C16284748780-1d6a99b39-431d-a426-e053-dadaa90af4c2SANITIZING SHAMPOO
79594-4000-32022-01-28C16284748780-1d6a99b39-431d-a426-e053-dadaa90af4c2SANITIZING SHAMPOO
79594-4000-42022-01-28C16284748780-1d6a99b39-431d-a426-e053-dadaa90af4c2SANITIZING SHAMPOO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79594-4000-1SEGUCLEAN250 mL in 1 BOTTLESHAMPOO2501
79594-4000-2SEGUCLEAN500 mL in 1 BOTTLESHAMPOO5001
79594-4000-3SEGUCLEAN1000 mL in 1 BOTTLESHAMPOO10001
79594-4000-4SEGUCLEAN5000 mL in 1 BOTTLESHAMPOO50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79594-4000SEGUCLEAN (BENZALKONIUM CHLORIDE) SHAMPOO [PRODUCTOS Y SERVICIOS DE LIMPIEZA SEGUCLEAN S.A. DE C.V.]1Legacy NDC, 4 package rows20200723_aafa0ca8-88c3-2df2-e053-2995a90a0a3a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79594-400079594-4000-1, 79594-4000-2, 79594-4000-3, 79594-4000-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
TRICLOSAN4NM5039Y5XIACT
ROSE OILWUB68Y35M7IACT
SODIUM LAURETH-5 SULFATE410Q7WN1BXIACT
DIETHANOLAMINEAZE05TDV2VIACT
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
aafa0ca8-88c4-2df2-e053-2995a90a0a3aaafa0ca8-88c3-2df2-e053-2995a90a0a3a2020-07-21WarningsExact identifier
spl id: aafa0ca8-88c4-2df2-e053-2995a90a0a3a
spl set id: aafa0ca8-88c3-2df2-e053-2995a90a0a3a

Reported adverse events (FAERS/openFDA)#

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