Natura Antibacterial Hand Soap Ocean Breeze

Natura Antibacterial Hand Ocean Breeze by

Drug Labeling and Warnings

Natura Antibacterial Hand Ocean Breeze by is a Otc medication manufactured, distributed, or labeled by PAPOUTSANIS S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURA ANTIBACTERIAL HAND OCEAN BREEZE- 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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Natura Antibacterial Hand Soap Ocean Breeze

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.

Do not use

in the eyes, if this happens rinse thoroughly with water

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 hands and forearms.
• Apply palmful to hands and forearms.
• Scrub thoroughly for 20 seconds.
• Rinse and repeat.
• 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

Aqua(Water), Cocamidopropyl Betaine, Decyl Glucoside, Lauryl Glucoside, Coco Glucoside, Glycerin, Parfum, Glyceryl Oleate, PEG-90 Glyceryl Isostearate, Laureth-2, Tetrasodium Glutamate Diacetate, Citric Acid, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Nitrate, Magnesium Chloride, CI 42090 (blue 1).

Company Information

PAPOUTSANIS S.A 34100 HALKIDA,

T: +30 22620 85000 - Made in Greece - www.papoutsanis.gr

Distributed by USA: 1796 Clove Rd, Staten Island, NY 10304, US

TEL: 1 718-447-1206

Product Packaging

PAPOUTSANIS

Natura

ANTIBACTERIAL

HAND SOAP

with Benzalkonium Chloride

OCEAN BREEZE

With Antibacterial Agent

Germ Fighter

400ml - 13.5 fl.oz.

NATURA ANTIBACTERIAL HAND OCEAN BREEZE 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79772-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCO GLUCOSIDE (UNII: ICS790225B)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-90 GLYCERYL ISOSTEARATE (UNII: 0MLT3369F0)
LAURETH-2 (UNII: D4D38LT1L5)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79772-002-01	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/05/2020	06/30/2021

Labeler - PAPOUTSANIS S.A. (728432860)

Revised: 6/2021

Document Id: c4e2f0ee-0c94-57d8-e053-2995a90ae0cb

34390-5

Set id: ac209d7f-84e4-30e4-e053-2995a90ac8fd

Version: 2

Effective Time: 20210616