FDA.reportPublic FDA data

AQUARELLE

Manufacturer
INDELPA, S.A DE C.V
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:08:01

Label at a glance#

ProductAQUARELLE
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE 0.12%

OTC - PURPOSE SECTION

Purpose: Antibacterial

INDICATIONS & USAGE SECTION

helps eliminate bacteria on hands

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

avoid contact with eyes.
In case of contact, flush with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Except under adult supervision.

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

INSTRUCTIONS FOR USE SECTION

wash hands and rise.

DOSAGE & ADMINISTRATION SECTION

Liquid.... Topical

INACTIVE INGREDIENT SECTION

Water, Sodium Lauryl Sulfate, Cocobetaine, Sodium Chloride, Glycerin USP,
Fragrance, Polysorbate 20, Methylchloroisotiazolinone/ Methylisotiazolinone, Citric
Acid, Color FD&C Blue # 1, Color FD&C Red # 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUARELLE SOAP 1AQUARELLE SOAP 1Hand Soap Antibacterial Fresh Scent

Hand Soap 250 ml- Dispensing

7.6 fl. oz (250 mL)

AQUARELLE SOAP 2AQUARELLE SOAP 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapPSN3
1053188benzalkonium chloride 1.2 MG/ML Medicated Liquid SoapSCD3
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-804-01AQUARELLE225 mL in 1 BOTTLELIQUID2253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-804AQUARELLE (BENZALKONIUM CHLORIDE) LIQUID [INDELPA, S.A DE C.V]3Legacy NDC, 1 package rows20240130_b62a0129-29de-3a27-e053-2a95a90a7f1a.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
70697-80470697-804-01

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
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYSORBATE 207T1F30V5YHIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
SODIUM CHLORIDE451W47IQ8XIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT

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
0dab4645-19c0-deca-e063-6394a90a52feb62a0129-29de-3a27-e053-2a95a90a7f1a2024-01-01WarningsExact identifier
spl id: 0dab4645-19c0-deca-e063-6394a90a52fe
spl set id: b62a0129-29de-3a27-e053-2a95a90a7f1a

Reported adverse events (FAERS/openFDA)#

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