FDA.reportPublic FDA data

lucas and zoe

Manufacturer
PAPOUTSANIS S.A.
Effective date
2021-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:49:00

Label at a glance#

Productlucas and zoe
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For handwashing to decrease bacteria on skin Recommended for repeated use.

Dosage and administration

Wet bar with water Lather vigorously and wash skin Scrub thoroughly for 20 seconds Rinse and repeat as necessary Dry skin thoroughly Children under six should be supervised while using this product

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on skin
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

OTC - DO NOT USE SECTION

In case of eye contact flush thoroughly with cool water. If irritation develops and persists, stop use and ask a doctor.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops and persists more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet bar with water
  • Lather vigorously and wash skin
  • Scrub thoroughly for 20 seconds
  • Rinse and repeat as necessary
  • Dry skin thoroughly
  • Children under six should be supervised while using this product

Other information

OTHER SAFETY INFORMATION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium Olivate, Sodium Cocoate, Aqua / Water, Parfum / Fragrance, Glycerin, Olea Europaea (Olive) Fruit Oil, Sodium Chloride, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Tetrasodium Glutamate Diacetate, Benzalkonium Chloride.

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug FactsPDPPDP

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79772-00379772-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM COCOATER1TQH25F4IIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
OLEA EUROPAEA FRUIT VOLATILE OIL8E7358CX1JIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
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
c59ae012-592d-ac16-e053-2a95a90ab515bda5a901-5eba-4a4a-e053-2a95a90a6e7c2021-06-25WarningsExact identifier
spl set id: bda5a901-5eba-4a4a-e053-2a95a90a6e7c

Reported adverse events (FAERS/openFDA)#

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