ZOONO HAND SANITIZER- benzalkonium chloride solution

Zoono germfree 24 Foaming Hand Sanitizer by

Drug Labeling and Warnings

Zoono germfree 24 Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ZOONO USA, LLC, Zoono USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic

Uses:

For Personal hand sanitizing and to reduce bacteria on the skin. Recommended for repeated use.

Warnings:

For external use only.

Do not use in the eyes

When using this product avoid contact with eyes. In case of eye contact flush eyes with water.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients:

Ethyl alcohol, Fragrances, Silica Complex (3-Trimethoxysilyl Propyl Dimethyl Octadecyl Ammonium Chloride), Water

Questions?

Telephone 1-844-966-6687 Monday through Friday 8:00am till 5:00pm EST

Directions:

Apply liberally to hands and gently rub until dry.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZOONO HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69221-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69221-203-03	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016
2	NDC: 69221-203-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016
3	NDC: 69221-203-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016
4	NDC: 69221-203-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016
5	NDC: 69221-203-06	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016
6	NDC: 69221-203-07	8 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/09/2016

Labeler - ZOONO USA, LLC (073623478)

Establishment
Name	Address	ID/FEI	Business Operations
Zoono USA, LLC		073623478	label(69221-203)