AQUARELLE

Manufacturer
INDELPA, S.A DE C.V
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:04

Label at a glance#

ProductAQUARELLE
Active ingredientBENZALKONIUM CHLORIDE
Label structure16 sections

Storage and handling

Store at room temperature. Cold weather may cloud this product. It´s antisceptic properties are not affected

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride....0.125%

OTC - PURPOSE SECTION

Antibaterial

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin. May be used on face, arms and legs

WARNINGS AND PRECAUTIONS SECTION

for external use only

OTC - DO NOT USE SECTION

If you are allergic to any of the ingredients

OTC - WHEN USING SECTION

Di not get into eyes. If contact occurs rinse thoroughly 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

INDICATIONS & USAGE SECTION

Throughly wipe hands and face as desired.

Allow to dry without wiping.

Discard wipe in trash receptacle after use. Do not flush

STORAGE AND HANDLING SECTION

Store at room temperature. Cold weather may cloud this product. It´s antisceptic properties are not affected

INACTIVE INGREDIENT SECTION

Demineralised water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Methylchloroisothiazolinone / Methylisothiazolinone, Fragrance, Aloe Vera Extract, Tretasodium EDTA, Citric Acid, D-alpha Tocopheryl Acetate.

DOSAGE & ADMINISTRATION SECTION

Dossage: swab

Administration: Topical

INSTRUCTIONS FOR USE SECTION

To dispense wipe: Peel back front label slowly. Remove wipes

To resela Pouch: Firmly run thumb over the label

WARNINGS SECTION

For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aquarelle 20saquarelle 20saquarelle waterfallaquarelle waterfallaquarelle 15 ctaquarelle 15 ctaquarelle 15 caseaquarelle 15 caseaquarelle 40aquarelle 40

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2276303benzalkonium Cl 0.125 % Medicated PadPSN4
2276303benzalkonium chloride 1.25 MG/ML Medicated PadSCD4
2276303benzalkonium chloride 0.125 % Medicated WipeSY4
2276303benzalkonium chloride 0.125 % Topical ClothSY4
2276303benzalkonium chloride 0.125 % Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-805-01AQUARELLE15 in 1 PACKAGECLOTH154
70697-805-01AQUARELLE30 in 1 CASECLOTH304
70697-805-02AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754
70697-805-02AQUARELLE24 in 1 CASECLOTH244
70697-805-03AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754
70697-805-03AQUARELLE12 in 1 CASECLOTH124
70697-805-04AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754
70697-805-04AQUARELLE24 in 1 CASECLOTH244
70697-805-05AQUARELLE16 in 1 BOXCLOTH164
70697-805-05AQUARELLE1 in 1 PACKAGECLOTH14
70697-805-06AQUARELLE24 in 1 CASECLOTH244
70697-805-06AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-805AQUARELLE (BENZALKONIUM CHLORIDE) CLOTH [INDELPA, S.A DE C.V]4Legacy NDC, 12 package rows20230111_b79fc794-5db3-a017-e053-2995a90a0b1d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70697-80570697-805-01, 70697-805-02, 70697-805-03, 70697-805-04, 70697-805-05, 70697-805-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
f1f19ceb-b1a5-6624-e053-2995a90ae432b79fc794-5db3-a017-e053-2995a90a0b1d2023-01-10WarningsExact identifier
spl id: f1f19ceb-b1a5-6624-e053-2995a90ae432
spl set id: b79fc794-5db3-a017-e053-2995a90a0b1d

Reported adverse events (FAERS/openFDA)#

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