lucas zoe antibacterial soap

lucas and zoe by

Drug Labeling and Warnings

lucas and zoe by is a Otc medication manufactured, distributed, or labeled by PAPOUTSANIS S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LUCAS AND ZOE- benzalkonium chloride soap 
PAPOUTSANIS S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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lucas zoe antibacterial soap

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

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

Warnings

For external use only.

Avoid contact with eyes.

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

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

Keep out of reach of children.

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

Directions

• 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

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

Inactive ingredients

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

LUCAS AND ZOE 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79772-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM COCOATE (UNII: R1TQH25F4I)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79772-003-01	115 g in 1 BOX; Type 0: Not a Combination Product	03/16/2021	06/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/16/2021	06/25/2021

Labeler - PAPOUTSANIS S.A. (728432860)

Establishment
Name	Address	ID/FEI	Business Operations
PAPOUTSANIS S.A.		728432860	manufacture(79772-003)

Revised: 6/2021

Document Id: c59ae012-592d-ac16-e053-2a95a90ab515

34390-5

Set id: bda5a901-5eba-4a4a-e053-2a95a90a6e7c

Version: 3

Effective Time: 20210625