Zoono Hand Sanitizer Alcohol-Free

Zoono Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

Zoono Alcohol Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zoono Holdings USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZOONO ALCOHOL FREE HAND SANITIZER- benzalkonium chloride solution 
Zoono Holdings USA LLC

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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Zoono Hand Sanitizer Alcohol-Free

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 develop

Keep out of reach of childres

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

Directions

Apply liberally to the hands and gently rub until dry.

Inactive Ingredients

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

Questions?

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

ZOONO ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69221-601
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: 69221-601-14	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020
2	NDC: 69221-601-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020
3	NDC: 69221-601-15	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020
4	NDC: 69221-601-13	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020
5	NDC: 69221-601-16	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/20/2020	03/31/2024

Labeler - Zoono Holdings USA LLC (073623478)

Registrant - Zoono Holdings USA LLC (073623478)

Revised: 12/2022

Document Id: efcd2530-aba4-50b5-e053-2a95a90a7365

34390-5

Set id: b4dcfd0f-e3b6-a7e9-e053-2a95a90a56c8

Version: 5

Effective Time: 20221214